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.

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The EC also approved Libtayo in advanced basal cell carcinoma (BCC).

The U.S. Food and Drug Administration approved Blueprint Medicines’ Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis.

The U.S. Food and Drug Administration approved Novartis’ blockbuster drug Cosentyx (secukinumab) for pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis. The new approval for Cosentyx marks the first for a pediatric patient population in the United States.

Bristol Myers Squibb

The U.S. Food and Drug Administration approved Bristol Myers Squibb’s oral drug Zeposia to treat adults with ulcerative colitis, a chronic inflammatory bowel disease.

The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Opdivo (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

Keytruda

The U.S. Food and Drug Administration approved Merck’s Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the first anti-PD-1 therapy approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients.