FDA granted Fast Track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer.
This week, Federal Judge Kacsmaryk of Northern District of Texas concluded that the FDA erred in 2000 when it granted Accelerated Approval to mifepristone as an agent to facilitate a medical abortion.
Pragmatica-Lung, the first study born from a broader effort by NCI, FDA, industry, academia, and advocacy groups to modernize the clinical trial process, has begun enrolling patients.
FDA last week issued a draft guidance that urges sponsors to conduct randomized controlled trials when they seek accelerated approval.
FDA granted full approval to Keytruda for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
FDA granted accelerated approval to Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
FDA approved Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.
The FDA Oncologic Drugs Advisory Committee March 9 voted 11:2 in favor the approval of Polivy (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treatment-naive diffuse large B-cell lymphoma.
FDA has approved an expanded indication for Eli Lilly and Company’s Verzenio (abemaciclib), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.
