FDA granted clearance to version 1.1 of the next generation SmartFrame Array Neuro Navigation System and Software, sponsored by ClearPoint Neuro Inc.
A commentary authored by seven researchers who participated in the FDA Oncology Center of Excellence “Conversations on Cancer,” held July 29, 2021, discussed the significant cancer disparities facing Asian Americans.
FDA accepted the supplemental Biologics License Application of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
Why is the April 21 ODAC different from all the other ODACs? At all other ODACs, a commercial sponsor gets to make a case. On April 21, only FDA’s voice will be heard.
FDA granted fast tack status to Bria-IMT for the treatment of metastatic breast cancer.
FDA approved Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.
FDA is requesting a total budget of $8.4 billion as part of the president’s fiscal year 2023 budget—a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level—for investments in critical public health modernization, core food safety and medical product safety programs, and other public health infrastructure.
The rapid acceleration of drug development has exponentially increased the therapeutic options available to patients with cancer.
FDA approved Opdualag (nivolumab and relatlimab-rmbw) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
