Daily Archives: August 25, 2021
Nivolumab has been approved by the FDA for use as an adjuvant treatment for urothelial carcinoma
August 25th, 2021 Urethral cancerAugust 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence following radical resection..... Read More
Dostarlimab-gxly receives accelerated approval from the FDA for dMMR advanced solid tumours
August 25th, 2021 CancerAugust 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) was given accelerated approval by the Food and Drug Administration for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumours, as determined by an FD.... Read More
Belzutifan has been approved by the FDA for malignancies linked to von Hippel-Lindau disease
August 25th, 2021 CancerAugust 2021: Belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor, has been approved by the Food and Drug Administration for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma (RCC).... Read More
The FDA has approved the combination of lenvatinib and pembrolizumab for advanced renal cell carcinoma
August 25th, 2021 Kidney cancerAugust 2021: The combination of lenvatinib (Lenvima, Eisai) and pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).CLEAR (.... Read More
Pembrolizumab has been approved by the FDA for high-risk early-stage triple-negative breast cancer
August 25th, 2021 Breast Cancer, CancerAugust 2021: Pembrolizumab (Keytruda, Merck) was approved by the FDA for high-risk, early-stage triple-negative breast cancer (TNBC) as a neoadjuvant treatment in combination with chemotherapy, and later as a single agent as adjuvant treatment f.... Read More
Pembrolizumab and lenvatinib have been approved by the FDA for advanced endometrial cancer
August 25th, 2021 Endometrial cancerAugust 2021: Pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) has been approved by the Food and Drug Administration for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-.... Read More
The FDA has approved belumosudil for the treatment of chronic graft-versus-host disease
August 25th, 2021 Bone marrow transplantAugust 2021: After failure of at least two prior lines of systemic therapy, the Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and paediatric patients 12 years and older w.... Read More
Daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone have been approved by the FDA for the treatment of multiple myeloma
August 25th, 2021 MyelomaAugust 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 for adult patients with multiple myeloma who have .... Read More
The FDA has given enfortumab vedotin-ejfv approval for the treatment of locally advanced or metastatic urothelial carcinoma
August 25th, 2021 Urethral cancerAugust 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 for adult patients with locally advanced or metast.... Read More
FDA has approved asparaginase erwinia chrysanthemi (recombinant) for leukaemia and lymphoma
August 25th, 2021 Leukemia, LymphomaAugust 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 the treatment of acute lymphoblastic leuk.... Read More