Rybrevant™ (amivantamab-vmjw) – New drug approval

Johnson & Johnson announced the FDA approval of Rybrevant (amivantamab-vmjw), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. May 21, 2021

Miacalcin® (calcitonin salmon) – First-time generic

Leucadia launched an AP-rated generic version of Mylan’s Miacalcin (calcitonin salmon) injection. May 17, 2021

Opdivo® (nivolumab) – Expanded indication

Bristol Myers Squibb announced the FDA approval of Opdivo (nivolumab), for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). May 20, 2021

Yervoy® (ipilimumab) – Expanded indication

The FDA approved Bristol Myers Squibb’s Yervoy (ipilimumab), in combination with Opdivo® (nivolumab), for the treatment of unresectable or metastatic melanoma in adult patients. May 23, 2021