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Dostarlimab-gxly receives accelerated approval from the FDA for dMMR endometrial cancer

August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) received accelerated approval from the Food and Drug Administration for adult patients with mismatch repair deficient (dMMR) recurrent or...

Nivolumab in addition to chemotherapy is approved by FDA for metastatic gastric cancer and esophageal adenocarcinoma

August 2021: For advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company)...

Sacituzumab govitecan receives fast approval from the FDA for advanced urothelial cancer

August 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) was given accelerated approval by the Food and Drug Administration for patients with locally advanced or metastatic urothelial...

Sacituzumab govitecan receives FDA approval for triple-negative breast cancer

August 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) gained regular FDA clearance for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have...

The FDA has approved idecabtagene vicleucel for the treatment of multiple myeloma

August 2021: The Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple...

Pembrolizumab has been approved by the FDA for the treatment of esophageal or gastroesophageal junction cancer

August 2021: Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy has been approved by the Food and Drug Administration...

The FDA has approved relugolix for the treatment of advanced prostate cancer

August 2021: The first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (ORGOVYX, Myovant Sciences, Inc.), was approved by the Food and Drug Administration on December...

Tivozanib has been approved by the FDA for the treatment of relapsed or refractory advanced renal cell carcinoma

August 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, has been approved by the FDA for adult patients with relapsed or refractory advanced renal...

Lorlatinib has been approved by the FDA for the treatment of metastatic ALK-positive NSCLC.

August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) received regular FDA approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase...

The FDA has granted axicabtagene ciloleucel expedited approval for relapsed or refractory follicular lymphoma.

August 2021: The FDA has given axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) expedited approval for adult patients with relapsed or refractory follicular lymphoma (FL) after...

Lorlatinib has been approved by the FDA for the treatment of metastatic ALK-positive NSCLC

August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) received regular FDA approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase...

Melphalan flufenamide receives approval from the FDA for relapsed or refractory multiple myeloma

August 2021: Melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone has been granted accelerated approval by the Food and Drug Administration for adult patients...

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