FDA Approvals – Jan 2021

In January  2021, the FDA approved the following new indications/Molecules.

• Combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).
• Daratumumab plus hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain (AL) amyloidosis.
• Fam-trastuzumab deruxtecan-nxki  for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 
• Crizotinib for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL. 

For Dec 2020 FDA approval, click here.