Xtandi Now Approved for Metastatic Castration-Sensitive Prostate Cancer
On December 16, 2019, the FDA approved a new indication for enzalutamide (Xtandi; Astellas Pharma) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC)....
View ArticleLynparza Indicated for Maintenance Treatment of Metastatic Pancreatic Cancer...
On December 27, 2019, the FDA accelerated the approval of a new indication for olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adults with metastatic pancreatic adenocarcinoma...
View ArticleKeytruda Indicated for BCG-Unresponsive High-Risk, Non–Muscle Invasive...
On January 8, 2020, the FDA accelerated the approval of a new indication for pembrolizumab (Keytruda; Merck & Co) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk,...
View ArticlePadcev, a Novel Targeted Therapy, FDA Approved for Advanced or Metastatic...
On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of...
View ArticleEnhertu, a Dual-Targeted Therapy, Approved for Metastatic HER2-Positive...
On December 23, 2019, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment...
View ArticleAyvakit First Targeted Therapy Approved for Gastrointestinal Stromal Tumors...
On January 9, 2020, the FDA accelerated the approval of avapritinib (Ayvakit; Blueprint Medicines Corporation), a kinase inhibitor, for the treatment of adults with unresectable or metastatic...
View ArticleTazverik First FDA-Approved Drug for Advanced Epithelioid Sarcoma Ineligible...
On January 23, 2020, the FDA accelerated the approval of tazemetostat (Tazverik; Epizyme Inc), an EZH2 methyltransferase blocker, for the treatment of patients aged ≥16 years with metastatic or...
View ArticleFDA Grants Priority Review to New Drug Application for the RET Kinase...
On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive...
View ArticleTazverik Receives FDA Approval as First Treatment Specifically for Metastatic...
On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in...
View ArticleFDA Grants Approval to Avapritinib for Patients with GIST
On January 9, 2020, the FDA approved avapritinib (Ayvakit; Blueprint Medicines), a kinase inhibitor, for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor...
View ArticleRecap of FDA Drug Approvals in 2019
According to the FDA’s Center for Drug Evaluation and Research’s (CDER) annual report, Advancing Health Through Innovation: New Drug Therapy Approvals 2019, the agency approved 48 novel drugs in 2019....
View ArticleZejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer
On October 23, 2019, the FDA approved a new indication for the PARP inhibitor niraparib (Zejula; Tesaro) for the treatment of patients with homologous recombination deficiency repair (HRD)-positive...
View ArticleFDA Approves Calquence for Adults with CLL or SLL
On November 21, 2019, the FDA accelerated the approval of acalabrutinib (Calquence; AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma. This drug was...
View ArticleTecentriq Approved with Chemotherapy for First-Line Treatment of Metastatic...
On December 3, 2019, the FDA approved atezolizumab (Tecentriq; Genentech), in combination with paclitaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults...
View ArticleZiextenzo Third Biosimilar to Neulasta Approved for Febrile Neutropenia
On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to...
View ArticleBrukinsa Receives Accelerated FDA Approval for Mantle-Cell Lymphoma
On November 14, 2019, the FDA granted accelerated approval to zanubrutinib capsules (Brukinsa; BeiGene), a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adults with mantle-cell...
View ArticleRegenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for...
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial...
View ArticleFDA Grants Priority Review to Keytruda for Patients with High-Risk,...
On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug...
View ArticleFDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with...
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell...
View ArticleNovember 25, 2019 – Oncology News & Updates
In This Article Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Despite Some Positive Trends, Report Confirms Lung Cancer...
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