Yescarta

The U.S. Food and Drug Administration approved Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

The U.S. Food and Drug Administration approved AbbVie’s Rinvoq (upadacitinib) for adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. 

AstraZeneca and Merck & Co. Inc. announced Lynparza (olaparib) was approved in the United States for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

Bristol Myers Squibb’s rheumatoid arthritis drug Orencia won marketing clearance as the first medicine approved for the prevention of moderate-to-severe acute graft versus host disease (aGvHD) in patients 2 years of age and older who have received unrelated donor hematopoietic stem cell transplantation.

The U.S. Food and Drug Administration approved Merck’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) for adjuvant treatment of renal cell carcinoma (RCC) patients at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions.

The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.

The U.S. Food and Drug Administration approved Eli Lilly’s Verzenio (abemaciclib) for a specific type of early breast cancer that is at high risk of recurrence after surgery. 

Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).

BeiGene Ltd.’s Brukinsa (zanubrutinib) received approval from the U.S. Food and Drug Administration for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).