FDA Approvals, News & Updates
Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them.
The Value of Pre–FDA Approval Healthcare Economic Information Exchange Between Payers and Drug Manufacturers
Adoption of healthcare economic information communication could improve formulary decision-making and increase patient access to drugs, suggest Peter R. Fendt, PharmD, MBA, and colleagues.
- Lynparza First Treatment Approved for Patients with Germline BRCA-Positive Metastatic Breast Cancer
- Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations
- Lutathera First Radioactive Drug Approved for Adults with Gastroenteropancreatic Neuroendocrine Tumors
- Zytiga Receives New Indication, with Prednisone, for Metastatic, High-Risk Castration-Sensitive Prostate Cancer
- Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer
- Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation
On August 17, 2017, the FDA approved a new indication for olaparib, in tablet form, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease completely or partially responded to chemotherapy that was platinum-based, regardless of their BRCA mutation status.
Following a year in which approximately 2 dozen cancer drugs were approved by the FDA, approvals in 2016 decreased by approximately 50% compared with 2015.
On December 19, 2016, the FDA granted accelerated approval to rucaparib (Rubraca; Clovis Oncology Inc), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation, and who have been treated with ≥2 chemotherapies.
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
The FDA has granted approval to daratumumab (Darzalex) for the treatment of patients with multiple myeloma who have received ≥1 previous therapies, in combination with dexamethasone and either lenalidomide or bortezomib.
On August 10, 2016, the FDA approved granisetron extended-release (Sustol; Heron Therapeutics) injection, the first extended-release 5-hydroxytryptamine (5-HT3) receptor antagonist, in combination with other antiemetic drugs in adults.
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Results 31 - 40 of 136
Results 31 - 40 of 136