Investigators from the National Institutes of Health (NIH) report 2 partial responses (PR) in 3 peripheral T-cell lymphoma (PTCL) patients and 1 PR in 2 double-hit diffuse large b-cell lymphoma...
On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
MISSISSAUGA, ON, July 13, 2023 /CNW/ - Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for Lynparza® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before Lynparza treatment is initiated.1
The addition of ibrutinib (Imbruvica) to bendamustine plus rituximab (Rituxan; BR) or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) did not lead to a statistically significant improvement in progression-free survival (PFS) vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma (MZL), according to findings from the phase 3 SELENE trial (NCT01974440) presented at the 17th Annual International Conference on Malignant Lymphoma.1
A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc's experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer.
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combination therapy with abiraterone and prednisone or prednisolone.
Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone demonstrated median overall survival (OS) of 42.1 months versus 34.7 months for abiraterone plus placebo. This result represents a 7.4-month absolute difference in median OS versus a standard of care (47.9% maturity, hazard ratio [HR] of 0.81, 95% confidence interval [CI] 0.67-1.00; p=0.0544).
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
LYNPARZA With Abiraterone and Prednisone Approved in the EU for mCRPC