Do Orphan Drugs Really Need Development Incentives?
Drugs approved for an “orphan” indication ended up making just as much money as their non-orphan counterparts, even though they were helped by incentives during development, researchers found. There was no significant difference in median 5-year net sales between orphan and non-orphan drugs ($719 million vs $812 million, P=0.09), reported Benjamin Rome, MD, MPH, of […]
FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC
In a near-unanimous vote on Friday, outside advisors to the FDA recommended a narrow indication should the agency approve olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC). In an 11-1 vote (with one abstention), the Oncologic Drugs Advisory Committee (ODAC) recommended that any approval be restricted to patients with […]
FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patients
The FDA expanded the indication for elexacaftor, tezacaftor, and ivacaftor (Trikafta) in cystic fibrosis to include even younger children, maker Vertex Pharmaceuticals announced. The three-drug combination’s expanded label now covers children ages 2 to 5 years who have cystic fibrosis and either a F508del mutation in the CFTR gene or a CFTR gene mutation that […]
Drugmaker Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancer
Clovis Oncology has voluntarily withdrawn the indication for rucaparib (Rubraca) as a third-line treatment in BRCA-mutated ovarian cancer after an overall survival (OS) analysis showed a signal for potential harm, according to a filing with the Securities and Exchange Commission (SEC). “Based on further discussions with the FDA following submission of ARIEL4 OS data previously […]