Safety concerns over the PARP inhibitor warranted the request for additional data.
An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that AstraZeneca Plc be required to submit further clinical data before its experimental ovarian cancer drug is approved.
The panel voted 11-2 that the company should complete a second trial to confirm results seen in a smaller study which, while positive, were not robust enough to convince the committee that they could be reproduced. Panel members expressed concern about a potential increased risk of secondary cancers in patients receiving the drug, olaparib, as well as side effects such as nausea and gastrointestinal disturbances.
The FDA is not obliged to follow the advice of its advisory panels but typically does so. Olaparib is one of several cancer drugs AstraZeneca flagged as having strong potential in its defense of a $118 billion take-over bid by Pfizer Inc.
Original report:
Source: Reuters
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
FDA Approves Tislelizumab for Advanced or Metastatic ESCC After Chemotherapy
March 15th 2024The FDA has approved tislelizumab-jsgr (Tevimbra) for single-agent use in adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.
Read More