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.Â
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.Â
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.
FDA accepted a supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia. The sNDA was granted priority review.
FDA issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care (The Cancer Letter, Feb. 4, 2022).Â
Wednesday, March 8, marks six months since FDA failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications.Â
