Pharmaceutical companies can expect accelerated drug development by using alternate endpoints instead of the gold standard of OS and PFS for oncology molecules.
Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the FDA confirmed in a new guidance document released this week.
The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics, is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC drugs.
Read the complete article at: http://bit.ly/1JghIHB
Source: Regulatory Guidance Professional Society
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
Read More