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Pembrolizumab and lenvatinib have been approved by the FDA for advanced endometrial cancer

August 2021: Pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) has been approved by the Food and Drug Administration for patients with advanced endometrial...

The FDA has approved belumosudil for the treatment of chronic graft-versus-host disease

August 2021: After failure of at least two prior lines of systemic therapy, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a...

Daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone have been approved by the FDA for the treatment of multiple myeloma

August 2021: Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) have been approved by the Food and Drug Administration in combination with pomalidomide and dexamethasone...

The FDA has given enfortumab vedotin-ejfv approval for the treatment of locally advanced or metastatic urothelial carcinoma

August 2021: Enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor combination, has been approved by the Food and Drug Administration...

FDA has approved asparaginase erwinia chrysanthemi (recombinant) for leukaemia and lymphoma

August 2021: The Food and Drug Administration has approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as part of a multi-agent chemotherapeutic regimen for...

Avapritinib has been approved by the FDA for advanced systemic mastocytosis

August 2021: The FDA approved avapritinib (AyvakitTM, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), which includes aggressive systemic mastocytosis (ASM), systemic...

Infigratinib receives accelerated approval from the FDA for metastatic cholangiocarcinoma

August 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor, has been granted accelerated approval by the Food and Drug Administration for adults with previously...

Sotorasib receives accelerated approval from the FDA for KRAS G12C mutant NSCLC

August 2021: The FDA granted accelerated approval to sotorasib (LumakrasTM, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally...

Amivantamab-vmjw receives fast approval from the FDA for metastatic non-small cell lung cancer

August 2021: The FDA granted amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, accelerated approval for...

Nivolumab has been approved by the FDA for resected esophageal or gastroesophageal junction cancer

August 2021: The FDA has approved Nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with fully resected oesophagus or gastroesophageal junction (GEJ) cancer who have received...

Pembrolizumab receives accelerated approval from the FDA for HER2-positive gastric cancer

August 2021: Pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy has been granted accelerated approval by the Food and Drug...

The FDA has granted loncastuximab tesirine-lpyl accelerated approval for large B-cell lymphoma

August 2021: The FDA granted loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, accelerated approval for adult patients with relapsed...

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