Rubraca® (Rucaparib) Approved In The U.S. As Monotherapy …
WEBMay 15, 2020 · BOULDER, Colo.–(BUSINESS WIRE)– Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca ® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who ...
Rucaparib or Physician’s Choice in Metastatic Prostate Cancer
WEBFeb 16, 2023 · In a phase 2 study, rucaparib, an inhibitor of poly (ADP-ribose) polymerase (PARP), showed a high level of activity in patients who had metastatic, castration-resistant prostate cancer associated...
FDA Approves Olaparib, Rucaparib to Treat Prostate Cancer
WEBJun 11, 2020 · UPDATE: According to results from a large clinical trial called TRITON3, treatment with rucaparib (Rubraca) improves how long some people with metastatic prostate cancer live without their cancer getting worse.
FDA grants accelerated approval to rucaparib for BRCA-mutated ...
WEBOn May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or...
Rucaparib | FDA - U.S. Food and Drug Administration
WEBFDA granted the rucaparib application breakthrough therapy designation, priority review status, and orphan drug designation. This application was approved two months before the PDUFA goal date.
EMA Recommends Extension of Therapeutic Indications for Rucaparib …
WEBOn 12 October 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product rucaparib (Rubraca).
BREAKING NEWS: FDA Approves Rucaparib For Treatment of …
WEBMay 15, 2020 · Today we are thrilled to announce that the U.S. Food and Drug Administration (FDA) approved rucaparib, a new medication to treat some patients with advanced prostate cancer. PCF science is proud to have been involved since the beginning, in every stage of the research that lead to this development.
Rucaparib efficacious in metastatic castration-resistant prostate …
WEBFeb 17, 2023 · For patients with metastatic castration-resistant prostate cancer, treatment with rucaparib is associated with significantly longer duration of imaging-based progression-free survival compared...
FDA Approval Summary: Rucaparib for the Treatment of Patients …
WEBNov 17, 2020 · The U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib in May 2020 for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)‐associated metastatic castrate‐resistant prostate cancer (mCRPC) who have been treated with androgen receptor‐directed therapy and a taxane.
Efficacy and safety of rucaparib treatment in patients with BRCA ...
WEBDec 8, 2022 · Here we report the final efficacy and safety results in heavily pretreated patients with ovarian cancer who received rucaparib in Study 10 Parts 2A and 2B.
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