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).
Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals’ Xywav for idiopathic hypersomnia in adults.
The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
After an earlier rejection from the U.S. Food and Drug Administration, Merck’s vaunted checkpoint inhibitor Keytruda won approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer.