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Drug approvals in Europe| EMA drug approvals in 2022 |European Commission News| iPharmaCenter

Updated: Mar 6

December 21, 2022

EMA approved Lynparza, Zytiga, and prednisone or prednisolone combination for metastatic castration-resistant prostate cancer.

Merck and AstraZeneca announced that the combination of Lynparza (olaparib), Zytiga (abiraterone), and prednisone or prednisolone was approved for treating metastatic castration-resistant prostate cancer.

The approval was based on the Phase 3 PROpel trial, demonstrating the efficacy of the Lynparza combination versus placebo. The combination was evaluated in patients with mCRPC undergoing first-line treatment following the failure of primary androgen deprivation therapy. Patients were randomized in a 1:1 ratio; the primary endpoint was progression-free survival versus placebo. The rPFS was 24.8 months in patients on the Lynparza combination versus 16.6 months in patients on placebo. A trend in overall survival favoring the Lynparza combination was demonstrated versus placebo.

Also read: Prostate cancer news | Updates

The safety profile was consistent with the previously reported profile of individual drugs.

In Europe, prostate cancer is the most common cancer in men. Nearly 473,000 cases were reported in 2020, causing 108,000 deaths.

In the US, FDA has extended the review time by three months, and it mentioned that it needs more time for complete evaluation.


November 23, 2022

Skyrizi is approved for Crohn's Disease in Europe.

AbbVie announced that Skyrizi (risankizumab) was approved by European Commission for treating adults with moderate to severe Crohn's disease. It is indicated for patients with inadequate response or intolerant to conventional or biological therapy.

The approval was based on ADVANCE induction, MOTIVATE induction and FORTIFY maintenance study.

Also read: Gastric cancer news