FDA Accepts Satraplatin NDA and Grants Priority Review

Publication
Article
OncologyONCOLOGY Vol 21 No 6
Volume 21
Issue 6

Spectrum Pharmaceuticals, Inc, recently announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the US Food and Drug Administration (FDA). A Prescription Drug User Fee Act date of August 15, 2007, has been established by the FDA for a decision regarding the approval of the satraplatin application. Satraplatin is an investigational drug for the treatment of hormone-refractory prostate cancer in patients who have failed prior chemotherapy.

Spectrum Pharmaceuticals, Inc, recently announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the US Food and Drug Administration (FDA). A Prescription Drug User Fee Act date of August 15, 2007, has been established by the FDA for a decision regarding the approval of the satraplatin application. Satraplatin is an investigational drug for the treatment of hormone-refractory prostate cancer in patients who have failed prior chemotherapy.

Articles in this issue
Further Perspectives on Inflammatory Breast Cancer
FDA Accepts Satraplatin NDA and Grants Priority Review
The Unfolding Story of Imatinib Mesylate for Chronic Myeloid Leukemia
Erlotinib Extends Life of Patients With Pancreatic Cancer
Inflammatory Breast Cancer: Still Poorly Characterized
Treatment of Localized Soft-Tissue Sarcoma: Lessons Learned
Chronic Phase Chronic Myeloid Leukemia: More Drugs, More Lives Saved, New Challenges
New Insights, Future Directions in Primary Cutaneous Lymphoproliferative Disorders
Quality of Cancer Care Measures for Breast and Colorectal Cancer Jointly Released
Data Available From Cetuximab Study in First-Line Treatment of Advanced Pancreatic Cancer
Adjuvant Therapy for Pancreatic Cancer: No 'Definite' Standard
Today's Forecast for the Adjuvant Treatment of Pancreatic Cancer: Clear or Cloudy?
What Is Your Skin Cancer IQ?
Optimal First-Line Treatment of Chronic Myeloid Leukemia: How to Use Imatinib and What Role for Newer Drugs?
Adjuvant Therapy for Pancreatic Cancer: To Treat or Not To Treat?
Recent Videos
Social workers and case managers may have access to institutional- or hospital-level grants that can reduce financial toxicity for patients undergoing cancer therapy.
Insurance and distance to a tertiary cancer center were 2 barriers to receiving high-quality breast cancer care, according to Rachel Greenup, MD, MPH.
Antibody-drug conjugates are effective, but strategies such as better understanding the mechanisms of action may lead to enhanced care for patients with cancer. Antibody-drug conjugates are effective, but strategies such as better understanding the mechanisms of action may lead to enhanced care for patients with cancer.
ADCs demonstrate superior efficacy vs chemotherapy but maintain a similar efficacy profile that requires multidisciplinary collaboration to optimally treat.
According to Aditya Bardia, MD, MPH, FASCO, antibody-drug conjugates are slowly replacing chemotherapy as a standard treatment for breast cancer.
Administering oral SERD-based regimens may enhance patients’ quality of life when undergoing treatment for ER-positive, HER2-negative breast cancer.
Gedatolisib-based triplet regimens may be effective among patients with prior endocrine resistance or rapid progression following frontline therapy.
Biochemical markers and advanced imaging modalities play a critical role in monitoring patients undergoing RLT therapy for metastatic prostate cancer.
Data support the use of radioligand therapy in combination with androgen receptor pathway inhibitors to optimize prostate cancer outcomes.
Leading experts in the breast cancer field highlight the use of CDK4/6 inhibitors, antibody-drug conjugates, and other treatment modalities.
Related Content
According to Rachel Greenup, MD, MPH, some of the barriers to getting optimal treatment for breast cancer include access, insurance, and baseline understanding or knowledge.

How to Mitigate the Emotional, Logistical, and Financial Burdens of Cancer Treatment?

Tim Cortese
November 29th 2025
Article

According to Rachel Greenup, MD, MPH, some of the barriers to getting optimal treatment for breast cancer include access, insurance, and baseline understanding or knowledge.

Presenting investigators at ESMO Congress 2025 highlight findings from clinical trials assessing novel therapeutics across different disease types.

What Were the Key Presentations at ESMO 2025? Oncology Experts Discuss

Sara A. Hurvitz, MD;Xiuning Le, MD, PhD;Erica L. Mayer, MD, MPH
October 27th 2025
Podcast

Presenting investigators at ESMO Congress 2025 highlight findings from clinical trials assessing novel therapeutics across different disease types.

Subgroup data from the ARASENS trial support darolutamide plus androgen deprivation therapy as a standard of care in metastatic HSPC regardless of age.

Darolutamide/ADT Improves Efficacy in Older Metastatic HSPC Population

Russ Conroy
November 23rd 2025
Article

Subgroup data from the ARASENS trial support darolutamide plus androgen deprivation therapy as a standard of care in metastatic HSPC regardless of age.

Upfront risk stratification for additional cardiovascular testing may help mitigate cardiovascular toxicities in breast cancer treatment.

Cardiovascular Considerations in Breast Cancer Treatment and Survivorship

Joseph S. Wallins, MD, MPH
September 8th 2025
Podcast

Up-front risk stratification for additional cardiovascular testing may help mitigate cardiovascular toxicities in breast cancer treatment.

According to the developers, giredestrant is the first oral SERD to display beneficial DFS in early-stage breast cancer in the adjuvant setting.

Giredestrant Exhibits DFS Improvement in Early-Stage Breast Cancer

Roman Fabbricatore
November 18th 2025
Article

According to the developers, giredestrant is the first oral SERD to display beneficial DFS in early-stage breast cancer in the adjuvant setting.

The FDA has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) in breast cancer, based on a review of various attributes, including safety and efficacy data.

FDA Approves Pertuzumab Biosimilar in Breast Cancer Indications

Tim Cortese
November 13th 2025
Article

The FDA has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) in breast cancer, based on a review of various attributes, including safety and efficacy data.