Kristie L. Kahl

The agency granted full approval to pemetrexed for injection (Pemfexy), a liquid injection and branded alternative to Alimta, for nonsquamous NSCLC.

A study of the Veterans Affairs health system found that, despite trends suggesting otherwise, African American men with prostate cancer had similar survival outcomes, compared with non-Hispanic white men.

Oncoprex in combination with osimertinib received fast track designation from the FDA to treat patients with non-small cell lung cancer.

The agency granted the immunoconjugate targeting B-cell maturation antigen priority review to belantamab mafodotin for the treatment of heavily pre-treated patients with relapsed or refractory multiple myeloma.

The FDA granted priority review to rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.

The FDA accepted and granted priority review to the supplemental biologics license application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer.

The FDA approved enfortumab vedotin-ejfv (Padcev)-the first drug to treat adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.

The FDA approved avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

The FDA approved pembrolizumab for the treatment of patients with BCG–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

The FDA approved olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.

The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The FDA granted accelerated approval to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

The FDA approved enzalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.

Five years of treatment with anastrozole safely and effectively prevented breast cancer recurrence in high-risk postmenopausal women at 10.9 years of follow-up.

T-DXd demonstrated improved and durable response rates in heavily pretreated patients with advanced HER2-positive breast cancer.

The addition of pertuzumab to the previous standard of trastuzumab plus chemotherapy as an adjuvant therapy for patients with operable HER2-positive early breast cancer continued to reduce the risk for recurrence and death during a 6-year updated analysis.

Adjuvant therapy with S-1, an oral fluoropyrimidine-based drug, plus endocrine therapy postoperatively significantly increased invasive disease-free survival (IDFS) in patients with HR-positive, HER2-negative breast cancer.

The Food and Drug Administration approved the first generic for everolimus, which can provide a safe, effective, lower cost alternative to the brand-name drug it references.

The combination use of polatuzumab-vedotin, obinutuzumab, and lenalidomide showed high complete response rates in patients with relapsed/refractory follicular lymphoma.

The FDA approved atezolizumab in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

The FDA granted a breakthrough therapy designation to abatacept for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors.

Sham Mailankody, MBBS, discussed the challenge of determining an optimal sequence of treatments in patients with relapsed/refractory multiple myeloma, and how head-to-head studies can help.

The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

The FDA accepted a supplemental biologics license application and granted a priority review to durvalumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer.

A new gene mutation, DUOX2, may cause a type of familial thyroid cancer, according to study results published in Cancer Research.

Robert A. Brodsky, MD discussed the study of a first-of-kind multi-antigen targeted off-the-shelf chimeric antigen receptor- natural killer cell therapy with engineered persistence that will be presented at the ASH Annual Meeting & Exposition.

Research on chimeric antigen receptor T-cell therapy to be presented at the ASH Annual Meeting & Exposition is set to address drawbacks associated with treatment.

As part of Project Orbis, The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.