FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma
On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC):
- nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy
- nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company)
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
On May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer
On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
FDA approves alpelisib for PIK3CA-related overgrowth spectrum
On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.
FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma
Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
FDA approves belzutifan for cancers associated with von Hippel-Lindau disease
FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer
FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma
FDA approves belumosudil for chronic graft-versus-host disease
Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who
- have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or
- are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma
Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
(PHESGO, Genentech, Inc.) for subcutaneous injection
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