FDA Approval Alert: The Need-to-Know |

FDA Approval Alert brings together the most up-to-date information on the latest FDA approvals in oncology. On this page, read, watch, and listen to the content comprising the breaking news, organized by drug indication. Clinical trial investigators and thought leaders provide their perspective on the newly approved agents and how they stand to change the oncology treatment paradigm.

In October 2024, the FDA granted accelerated approval to asciminib as a therapy for adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.
Leukemia
Asciminib in Ph+ Chronic Myeloid Leukemia in Chronic Phase
In October 2024, the FDA granted accelerated approval to asciminib as a therapy for adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.
In October 2024, the FDA approved zolbetuximab-clzb plus fluoropyrimidine- and platinum-based chemotherapy as frontline therapy for patients with locally advanced unresectable or metastatic HER2-negative, Claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma.
Gastrointestinal Cancer
Zolbetuximab/Chemotherapy in Advanced CLDN18.2+ Gastric/GEJ Adenocarcinoma
In October 2024, the FDA approved zolbetuximab-clzb plus fluoropyrimidine- and platinum-based chemotherapy as frontline therapy for patients with locally advanced unresectable or metastatic HER2-negative, Claudin 18.2–positive gastric or gastroesophageal junction adenocarcinoma.
In October 2024, the FDA approved inavolisib in combination with palbociclib and fulvestrant for those with endocrine-resistant, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations.
Breast Cancer
Inavolisib/Palbociclib/Fulvestrant in PIK3CA+ Advanced Breast Cancer
In October 2024, the FDA approved inavolisib in combination with palbociclib and fulvestrant for those with endocrine-resistant, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations.
In October 2024, the FDA approved nivolumab plus platinum-doublet chemotherapy for neoadjuvant treatment followed by single-agent nivolumab after surgery for patients with resectable non–small cell lung cancer with EGFR mutations or ALK rearrangements.
Non-Small Cell Lung Cancer (NSCLC)
Perioperative Nivolumab/Chemotherapy in Resectable NSCLC
In October 2024, the FDA approved nivolumab plus platinum-doublet chemotherapy for neoadjuvant treatment followed by single-agent nivolumab after surgery for patients with resectable non–small cell lung cancer with EGFR mutations or ALK rearrangements.
In September 2024, the FDA approved osimertinib for patients with EGFR exon 19 deletions or exon 21 L858R mutations in locally advanced, unresectable stage III non–small cell lung cancer as detected by an FDA-approved test.
Non-Small Cell Lung Cancer (NSCLC)
Osimertinib in Advanced EGFR-Mutated NSCLC
In September 2024, the FDA approved osimertinib for patients with EGFR exon 19 deletions or exon 21 L858R mutations in locally advanced, unresectable stage III non–small cell lung cancer as detected by an FDA-approved test.
In September 2024, the FDA approved isatuximab-irfc plus bortezomib, lenalidomide, and dexamethasone (Isa-VRd) as a treatment for patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
Multiple Myeloma
Isatuximab/VRd in Transplant-Ineligible NDMM
In September 2024, the FDA approved isatuximab-irfc plus bortezomib, lenalidomide, and dexamethasone (Isa-VRd) as a treatment for patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
In September 2024, the FDA approved amivantamab-vmjw plus carboplatin and pemetrexed for patients with locally advanced or metastatic non–small cell lung cancer who have EGFR exon 19 deletions or exon 21 L858R substitution mutations following progression on or after treatment with an EGFR tyrosine kinase inhibitor.
Non-Small Cell Lung Cancer (NSCLC)
Amivantamab/Chemotherapy in EGFR-Mutated NSCLC
In September 2024, the FDA approved amivantamab-vmjw plus carboplatin and pemetrexed for patients with locally advanced or metastatic non–small cell lung cancer who have EGFR exon 19 deletions or exon 21 L858R substitution mutations following progression on or after treatment with an EGFR tyrosine kinase inhibitor.
In September 2024, the FDA approved ribociclib plus an aromatase inhibitor as adjuvant treatment for patients with hormone receptor–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.
Breast Cancer
Ribociclib/NSAI in HR+/HER2- Stage II-III Early Breast Cancer
In September 2024, the FDA approved ribociclib plus an aromatase inhibitor as adjuvant treatment for patients with hormone receptor–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.
In August 2024, the FDA approved amivantamab-vmjw in combination with lazertinib as frontline therapy for patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer.
Non-Small Cell Lung Cancer (NSCLC)
Amivantamab/Lazertinib in Advanced EGFR+ NSCLC
In August 2024, the FDA approved amivantamab-vmjw in combination with lazertinib as frontline therapy for patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer.
In August 2024, the FDA approved neoadjuvant durvalumab plus platinum-containing chemotherapy followed by single-agent durvaumab as adjuvant treatment for patients with resectable non–small cell lung cancer who do not have a known EGFR mutation or ALK rearrangement.
Non-Small Cell Lung Cancer (NSCLC)
Perioperative Durvalumab in Resectable NSCLC
In August 2024, the FDA approved neoadjuvant durvalumab plus platinum-containing chemotherapy followed by single-agent durvaumab as adjuvant treatment for patients with resectable non–small cell lung cancer who do not have a known EGFR mutation or ALK rearrangement.
In August 2024, the FDA approved axatilimab-csfr for patients who weigh at least 40 kg with chronic graft-versus-host disease after progression on 2 prior lines of systemic therapy.
Hematologic Oncology
Axatilimab in Pediatric/Adult Chronic GVHD
In August 2024, the FDA approved axatilimab-csfr for patients who weigh at least 40 kg with chronic graft-versus-host disease after progression on 2 prior lines of systemic therapy.
In August 2024, the FDA denileukin diftitox-cxdl for patients with relapsed/refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy.
Lymphoma
Denileukin Diftitox in Relapsed/Refractory Cutaneous T-Cell Lymphoma
In August 2024, the FDA denileukin diftitox-cxdl for patients with relapsed/refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy.
In August 2024, the FDA approved vorasidenib (Voranigo) for patients 12 years and older with grade 2 astrocytoma or oligodendroglioma harboring IDH1 or IDH2 mutations.
Brain Cancer
Vorasidenib in Grade 2 IDH+ Astrocytoma/Oligodendroglioma
In August 2024, the FDA approved vorasidenib (Voranigo) for patients 12 years and older with grade 2 astrocytoma or oligodendroglioma harboring IDH1 or IDH2 mutations.
In August 2024, the FDA granted accelerated approval to afamitresgene autoleucel as a treatment for adult patients with metastatic or unresectable synovial sarcoma previously treated with chemotherapy.
Sarcoma
Afamitresgene Autoleucel in Unresectable Synovial Sarcoma
In August 2024, the FDA granted accelerated approval to afamitresgene autoleucel as a treatment for adult patients with metastatic or unresectable synovial sarcoma previously treated with chemotherapy.
Dostarlimab/Chemotherapy in Advanced or Recurrent Endometrial Cancer | Image Credit: © freshidea - stock.adobe.com.
Endometrial Cancer
Dostarlimab/Chemotherapy in Advanced or Recurrent Endometrial Cancer
In August 2024, the FDA expanded approval status for dostarlimab-gxly plus carboplatin/paclitaxel followed by single-agent dostarlimab to include all adult patients with primary advanced or recurrent endometrial cancer.
In July 2024, the FDA approved daratumumab and hyaluronidase-fihj plus bortezomib, lenalidomide and dexamethasone as induction and consolidation therapy for patients with newly diagnosed multiple myeloma eligible to undergo ASCT.
Multiple Myeloma
Subcutaneous Daratumumab Combo in Newly Diagnosed Multiple Myeloma
In July 2024, the FDA approved daratumumab and hyaluronidase-fihj plus bortezomib, lenalidomide and dexamethasone as induction and consolidation therapy for patients with newly diagnosed multiple myeloma eligible to undergo ASCT.
In June 2024, the FDA granted accelerated approved epcoritamab-bysp as a treatment for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy.
Lymphoma
Epcoritamab in Relapsed/Refractory Follicular Lymphoma
In June 2024, the FDA granted accelerated approved epcoritamab-bysp as a treatment for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy.
In June 2024, the FDA granted accelerated approval to adagrasib plus cetuximab for patients with KRAS G12C-mutated colorectal cancer.
Colorectal Cancer
Adagrasib/Cetuximab in KRAS G12C-Mutated Colorectal Cancer
In June 2024, the FDA granted accelerated approval to adagrasib plus cetuximab for patients with KRAS G12C-mutated colorectal cancer.
In June 2024, the FDA approved pembrolizumab plus carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma.
Endometrial Cancer
Pembrolizumab/Chemotherapy in Advanced/Recurrent Endometrial Carcinoma
In June 2024, the FDA approved pembrolizumab plus carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma.
In June 2024, the FDA approved blinatumomab as a treatment for adult and pediatric patients 1 month or older with CD19-positive Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia.
Leukemia
Blinatumomab in CD19+ Ph– B-Cell Precursor Acute Lymphoblastic Leukemia
In June 2024, the FDA approved blinatumomab as a treatment for adult and pediatric patients 1 month or older with CD19-positive Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia.
In June 2024, the FDA approved durvalumab in combination with carboplatin and paclitaxel followed by durvalumab maintenance for adults with mismatch repair deficient primary advanced or recurrent endometrial cancer.
Endometrial Cancer
Durvalumab/Chemotherapy in dMMR Advanced Endometrial Cancer
In June 2024, the FDA approved durvalumab in combination with carboplatin and paclitaxel followed by durvalumab maintenance for adults with mismatch repair deficient primary advanced or recurrent endometrial cancer.
In June 2024, the FDA granted accelerated approval to repotrectinib in adult and pediatric patients who are 12 years and older with NTRK gene fusion-positive solid tumors.
Oncology
Repotrectinib in NTRK Gene Fusion-Positive Solid Tumors
In June 2024, the FDA granted accelerated approval to repotrectinib in adult and pediatric patients who are 12 years and older with NTRK gene fusion-positive solid tumors.
In June 2024, the FDA granted full approval to selpercatinib as a treatment for patients 2 years and older with RET fusion-positive advanced or metastatic thyroid cancer.
Thyroid Cancer
Selpercatinib in RET+ Thyroid Cancer
In June 2024, the FDA granted full approval to selpercatinib as a treatment for patients 2 years and older with RET fusion-positive advanced or metastatic thyroid cancer.
In May 2024, the FDA approved lisocabtagene maraleucel as a treatment for patients with relapsed/refractory mantle cell lymphoma.
Lymphoma
Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma
In May 2024, the FDA approved lisocabtagene maraleucel as a treatment for patients with relapsed/refractory mantle cell lymphoma.
In May 2024, the FDA granted accelerated approval to tarlatamab-dlle for patients with extensive-stage small cell lung cancer who have progressed on platinum-based chemotherapy.
Small Cell Lung Cancer (SCLC)
Tarlatamab in Extensive-Stage Small Cell Lung Cancer
In May 2024, the FDA granted accelerated approval to tarlatamab-dlle for patients with extensive-stage small cell lung cancer who have progressed on platinum-based chemotherapy.
In May 2024, the FDA granted accelerated approval to lisocabtagene maraleucel as a treatment for adult patients with relapsed/refractory follicular lymphoma following 2 or more prior lines of systemic therapy.
Lymphoma
Lisocabtagene Maraleucel in Relapsed/Refractory Follicular Lymphoma
In May 2024, the FDA granted accelerated approval to lisocabtagene maraleucel as a treatment for adult patients with relapsed/refractory follicular lymphoma following 2 or more prior lines of systemic therapy.
In April 2024, the FDA approved tisotumab vedotin-tftv for patients with recurrent or metastatic cervical cancer that has progressed following prior chemotherapy.
Cervical Cancer
Tisotumab Vedotin for Recurrent/Metastatic Cervical Cancer
In April 2024, the FDA approved tisotumab vedotin-tftv for patients with recurrent or metastatic cervical cancer that has progressed following prior chemotherapy.
In April 2024, the FDA approved alectinib for the adjuvant treatment of patients with ALK-positive non–small cell lung cancer with tumors that are at least 4 cm or node-positive as detected by an FDA-approved test.
Non-Small Cell Lung Cancer (NSCLC)
Alectinib for Early-Stage ALK+ NSCLC
In April 2024, the FDA approved alectinib for the adjuvant treatment of patients with ALK-positive non–small cell lung cancer with tumors that are at least 4 cm or node-positive as detected by an FDA-approved test.
In April 2024, the FDA approved nogapendekin alfa-inbakicept plus Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMBIC) with carcinoma in-situ.
Bladder Cancer
Nogapendekin Alfa-inbakicept/BCG in BCG-unresponsive NMIBC
In April 2024, the FDA approved nogapendekin alfa-inbakicept plus Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMBIC) with carcinoma in-situ.
In April 2024, idecabtagene vicleucel was approved by the FDA for the treatment of relapsed/refractory multiple myeloma after at least 2 prior lines of therapy that included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Multiple Myeloma
Ide-Cel in Previously Treated Multiple Myeloma
In April 2024, idecabtagene vicleucel was approved by the FDA for the treatment of relapsed/refractory multiple myeloma after at least 2 prior lines of therapy that included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
In March 2024, The FDA granted approval to mirvetuximab soravtansine-gynx as a treatment for patients with folate receptor alpha–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Ovarian Cancer
Mirvetuximab Soravtansine in FRα+ Ovarian Cancer
In March 2024, The FDA granted approval to mirvetuximab soravtansine-gynx as a treatment for patients with folate receptor alpha–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In March 2024, The FDA granted accelerated approval to ponatinib in combination with chemotherapy as a treatment for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.
Leukemia
Ponatinib/Chemotherapy in Ph+ Acute Lymphoblastic Leukemia
In March 2024, The FDA granted accelerated approval to ponatinib in combination with chemotherapy as a treatment for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.
In March 2024, the FDA approved tislelizumab-jsgr monotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy.
Gastrointestinal Cancer
Tislelizumab in Metastatic Esophageal Squamous Cell Carcinoma
In March 2024, the FDA approved tislelizumab-jsgr monotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy.
Enfortumab Vedotin Plus Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
Genitourinary Cancers
Enfortumab Vedotin Plus Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma
In December 2023, enfortumab vedotin-ejfv plus pembrolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial cancer.
Liso-Cel for Relapsed/Refractory CLL
Lymphoma
Liso-Cel for Relapsed/Refractory CLL/SLL
The FDA has approved lisocabtagene maraleucel as a treatment for adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
In March 2024, the FDA granted accelerated approval to nivolumab plus cisplatin and gemcitabine as first-line treatment for patients with unresectable or metastatic urothelial carcinoma.
Bladder Cancer
Nivolumab Plus Cisplatin/Gemcitabine for Unresectable Urothelial Carcinoma
In March 2024, the FDA granted accelerated approval to nivolumab plus cisplatin and gemcitabine as first-line treatment for patients with unresectable or metastatic urothelial carcinoma.
In March 2024, the FDA approved inotuzumab ozogamicin as a treatment for pediatric patients who are 1 year or older diagnosed with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
Leukemia
Inotuzumab Ozogamicin in Pediatric CD22+ ALL
In March 2024, the FDA approved inotuzumab ozogamicin as a treatment for pediatric patients who are 1 year or older diagnosed with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
In March 2024, the FDA approved amivantamab-vmjw in combination with carboplatin and pemetrexed as frontline therapy for patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations.
Non-Small Cell Lung Cancer (NSCLC)
Amivantamab/Chemo in EGFR Exon 20+ NSCLC
In March 2024, the FDA approved amivantamab-vmjw in combination with carboplatin and pemetrexed as frontline therapy for patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations.
In March 2024, The FDA granted accelerated approval to zanubrutinib plus obinutuzumab for the treatment of patients with relapsed/refractory follicular lymphoma following 2 previous lines of treatment.
Lymphoma
Zanubrutinib/Obinutuzumab for Relapsed/Refractory Follicular Lymphoma
In March 2024, The FDA granted accelerated approval to zanubrutinib plus obinutuzumab for the treatment of patients with relapsed/refractory follicular lymphoma following 2 previous lines of treatment.
Momelotinib for Myelofibrosis With Anemia
Hematologic Oncology
Momelotinib for Myelofibrosis With Anemia
In September 2023, momelotinib was approved for the treatment of patients with intermediate- or high-risk myelofibrosis, including primary and secondary myelofibrosis, who are experiencing anemia.
Toripalimab for Recurrent/Metastatic Nasopharyngeal Carcinoma
Head & Neck Cancer
Toripalimab for Recurrent/Metastatic Nasopharyngeal Carcinoma
Oct 28, 2023 8:52 PM
In October 2023, the FDA approved frontline toripalimab-tpzi plus cisplatin and gemcitabine for adult patients with metastatic or locally advanced nasopharyngeal carcinoma, as well as single-agent toripalimab for recurrent, unresectable, or metastatic disease that has progressed on or following prior chemotherapy.
Pembrolizumab/Chemoradiation in Stage III/IVA Cervical Cancer
Cervical Cancer
Pembrolizumab/Chemoradiation in Stage III/IVA Cervical Cancer
In January 2024, the FDA approved pembrolizumab in combination with external beam radiotherapy, concurrent chemotherapy, and brachytherapy for patients with FIGO stage III to IVA cervical cancer.
Nirogacestat in Desmoid Tumors
Sarcoma
Nirogacestat in Desmoid Tumors
In November 2023, the FDA approved nirogacestat as a treatment for patients with progressing desmoid tumors that require systemic therapeutics.
Capivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast Cancer
Breast Cancer
Capivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast Cancer
In November 2023, the FDA approved capivasertib plus fulvestrant for patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative with 1 or more PIK3CA, AKT1, or PTEN alterations, and has progressed on or after 1 endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant treatment.
Fruquintinib for Previously Treated Metastatic Colorectal Cancer
Gastrointestinal Cancer
Fruquintinib for Previously Treated Metastatic Colorectal Cancer
In November 2023, the FDA approved fruquintinib for patients with previously treated metastatic colorectal cancer based on results from the phase 3 FRESCO-2 trial.
Luspatercept for Anemia Related to Low-Risk Myelodysplastic Syndrome
Hematologic Oncology
Luspatercept for Anemia Related to Low-Risk Myelodysplastic Syndrome
In August 2023, the FDA approved luspatercept-aamt for patients with lower-risk myelodysplastic syndrome (MDS) with anemia in the first line
In July 2023, the FDA approved dostarlimab plus chemotherapy as a frontline treatment option for patients with primary advanced or recurrent mismatch repair deficient or microsatellite instability–high endometrial cancer.
Endometrial Cancer
Dostarlimab Plus Chemotherapy in Advanced dMMR/MSI-H Endometrial Cancer
In July 2023, the FDA approved dostarlimab plus chemotherapy as a frontline treatment option for patients with primary advanced or recurrent mismatch repair deficient or microsatellite instability–high endometrial cancer.
Olaparib Plus Abiraterone and Prednisone/Prednisolone in BRCA-Mutated mCRPC
Genitourinary Cancers
Olaparib Plus Abiraterone and Prednisone/Prednisolone in BRCA-Mutated mCRPC
In May 2023, the FDA approved olaparib plus abiraterone and prednisone or prednisolone for patients with BRCA-mutated metastatic castration-resistant prostate cancer as determined by an FDA-approved test.
Polatuzumab Vedotin/R-CHP in Previously Untreated DLBCL
Hematologic Oncology
Polatuzumab Vedotin/R-CHP in Previously Untreated DLBCL
In April 2023, the FDA approved polatuzumab vedotin-piiq in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as a treatment for patients with previously untreated diffuse large B-cell lymphoma.
Enfortumab Vedotin-ejfv Plus Pembrolizumab for Urothelial Cancer
Genitourinary Cancers
Enfortumab Vedotin-ejfv Plus Pembrolizumab for Urothelial Cancer
In April 2023, the FDA approved enfortumab vedotin-ejfv plus pembrolizumab as a combination therapy for patients with locally advanced or metastatic urothelial cancer who cannot receive cisplatin-based chemotherapy.
Sacituzumab Govitecan-hziy in Pre-Treated HR+/HER2– Advanced Breast Cancer
Breast Cancer
Sacituzumab Govitecan-hziy in Pre-Treated HR+/HER2– Advanced Breast Cancer
In February 2023, the FDA approved sacituzumab govitecan-hziy for the treatment of patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer in patients who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
Elacestrant for ER+/HER2– Advanced Metastatic Breast Cancer
Breast Cancer
Elacestrant for ER+/HER2– Advanced Metastatic Breast Cancer
In January 2023, the FDA approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least 1 line of therapy.
Pirtobrutinib for Relapsed/Refractory MCL
Hematologic Oncology
Pirtobrutinib for Relapsed/Refractory MCL
In January 2023, the FDA gave accelerated approval to pirtobrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma following at least 2 prior lines of therapy.
Adjuvant Pembrolizumab for Resected NSCLC
Lung Cancer
Adjuvant Pembrolizumab for Resected NSCLC
In January 2023, the FDA approved adjuvant pembrolizumab for the treatment of completely resected non-small cell lung cancer.
Tucatinib Plus Trastuzumab for Advanced HER2+ Metastatic CRC
Gastrointestinal Cancer
Tucatinib Plus Trastuzumab for Advanced HER2+ Metastatic CRC
In January 2023, the FDA has given tucatinib in combination with trastuzumab accelerated approval by the FDA for the treatment of patients with RAS wild-type, HER2-positive metastatic colorectal cancer who have received at least 1 line of treatment for unresectable or metastatic disease.
Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma
Hematologic Oncology
Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma
In December 2022, the FDA has approved mosunetuzumab-axgb for patients with relapsed/refractory follicular lymphoma after 2 prior lines of therapy.
Adagrasib for KRAS G12C–Mutated NSCLC
Lung Cancer
Adagrasib for KRAS G12C–Mutated NSCLC
In December 2022, adagrasib was granted accelerated approval by the FDA for patients with KRAS G12C–mutated non–small cell lung cancer, as determined by an FDA-approved test.
Tremelimumab Plus Durvalumab and Chemotherapy in Advanced Non–Small Cell Lung Cancer
Lung Cancer
Tremelimumab Plus Durvalumab and Chemotherapy in Advanced Non–Small Cell Lung Cancer
In November 2022, the FDA approved tremelimumab plus durvalumab and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer who have an EGFR mutation or ALK alteration.
Mirvetuximab Soravtansine Folate Receptor-α-Positive Platinum-Resistant Ovarian Cancer
Gynecologic Cancers
Mirvetuximab Soravtansine Folate Receptor-α-Positive Platinum-Resistant Ovarian Cancer
In November 2022, mirvetuximab soravtansine-gynx was given accelerated approval by the FDA for the treatment of patients with folate receptor-α-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer cancer who have been treated with 1 to 3 lines of prior therapy.
Tremelimumab Plus Durvalumab for Unresectable Hepatocellular Carcinoma
Gastrointestinal Cancer
Tremelimumab Plus Durvalumab for Unresectable Hepatocellular Carcinoma
In October 2022, the FDA approved tremelimumab and durvalumab for patients with unresectable hepatocellular carcinoma.
Teclistamab-cqyv for Relapsed/Refractory Multiple Myeloma
Hematologic Oncology
Teclistamab-cqyv for Relapsed/Refractory Multiple Myeloma
In October 22, the FDA granted accelerated approval to teclistamab-cqvy for patients with relapsed/refractory multiple myeloma.
Darolutamide Plus Docetaxel for Metastatic HSPC
Genitourinary Cancers
Darolutamide Plus Docetaxel for Metastatic HSPC
Aug 5, 2022 7:59 PM
In August 2022, the FDA granted approval to oral darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Betibeglogene Autotemcel for Transfusion-Dependent Beta-Thalassemia
Hematologic Oncology
Betibeglogene Autotemcel for Transfusion-Dependent Beta-Thalassemia
In August 2022, the FDA approved betibeglogene autotemcel for adult and pediatric patients with β-thalassemia who need regular red blood cell infusions.
Liso-Cel for Relapsed/Refractory LBCL in Second Line
Hematologic Oncology
Liso-Cel for Relapsed/Refractory LBCL in Second Line
In June 2022, the FDA approved lisocabtagene maraleucel as treatment for relapsed/refractory large B-cell lymphoma following 1 prior line of therapy.
Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma
Gastrointestinal Cancer
Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma
In May 2022, nivolumab plus chemotherapy and nivolumab plus ipilimumab was approved by the FDA as a treatment for patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression.
Trastuzumab Deruxtecan for HER2-Positive Breast Cancer
Breast Cancer
Trastuzumab Deruxtecan for HER2-Positive Breast Cancer
In May 2022, the FDA approved the use of fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2 treatment in the metastatic, neoadjuvant, or adjuvant setting followed by disease recurrence during treatment or within 6 months of completing therapy.
Pembrolizumab for Advanced MSI-H/dMMR Endometrial Cancer
Gynecologic Cancers
Pembrolizumab for Advanced MSI-H/dMMR Endometrial Cancer
In March 2022, the FDA approved pembrolizumab for advanced microsatellite instability–high or mismatch repair–deficient advanced endometrial cancer following prior systemic therapy in any setting.
Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma Following Chemoimmunotherapy
Hematologic Oncology
Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma Following Chemoimmunotherapy
In April 2022, axicabtagene ciloleucel was approved by the FDA for the treatment of adult patients with large B-cell lymphoma whose disease was refractory to or which relapsed within 12 months after first-line chemoimmunotherapy.
177Lu-PSMA-617 for Pretreated PSMA+ Metastatic Castration-Resistant Prostate Cancer
Genitourinary Cancers
177Lu-PSMA-617 for Pretreated PSMA+ Metastatic Castration-Resistant Prostate Cancer
Mar 1, 2022 7:48 PM
In March 2022, the FDA granted approval to the targeted radioligand 177Lu-PSMA-617 for the treatment of patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously been treated with an androgen-receptor pathway inhibitor and taxane-based chemotherapy.
In February 2022, the FDA granted accelerated approval to pacritinib for patients with severe thrombocytopenia.
Hematologic Oncology
Pacritinib for Myelofibrosis With Severe Thrombocytopenia
In February 2022, the FDA granted accelerated approval to pacritinib for intermediate or high-risk primary or secondary myelofibrosis with severe thrombocytopenia.
Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
Hematologic Oncology
Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma
In February 2022, the FDA approved ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy.
Pafolacianine for Ovarian Cancer Detection During Surgery
Gynecologic Cancers
Pafolacianine for Ovarian Cancer Detection During Surgery
Jan 24, 2022 6:00 PM
In November 2021, the FDA approved pafolacianine for use as an imaging drug for identifying lesions in patients with ovarian cancer during surgery.