Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say. Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the […]
FDA has granted regular approval to Retevmo (selpercatinib) adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
FDA has approved Pedmark to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.
FDA has issued a safety alert informing patients and providers about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare.
FDA issued a revised draft guidance for industry, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to frequently asked questions about FDA’s processes, policies, and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use.
FDA accepted for review a Biologics License Application from ImmunityBio, Inc. for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
FDA has granted Fast Track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk myelodysplastic syndromes (MDS).
FDA accepted the Biologics License Application and granted priority review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
FDA approved Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR T-cell therapy, for the treatment of adult patients with large B-cell lymphoma
FDA issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.”
