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JohnWayne

07/27/17 10:12 AM

#212690 RE: maverick_1 #212687

AZN/MRK: this caught me by surprise. I guess it gives MRK a little more diversification in their oncology portfolio, and gives AZN a chance to hitch to what's becoming the leading PD-1 esp after MYSTIC failure? Seems like a better deal for AZN than for MRK but maybe I'm missing something...

DewDiligence

01/12/18 11:57 AM

#216573 RE: maverick_1 #212687

(CLVS/TSRO)—FDA approves AZN/MRK’s Lynparza for BRCA-mutation breast cancer:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592347.htm

Lynparza—and the PARP inhibitors from CLVS (Rubraca) and TSRO (Zejula)— are all FDA-approved for BRCA-mutation ovarian cancer, but Lynparza is the only one (for now) with an FDA indication for breast cancer.

MYGN supplies the companion diagnostic for Lynparza.

DewDiligence

04/24/20 12:50 PM

#231478 RE: maverick_1 #212687

MRK/AZN—Lynparza shows statsig-superior OS to hormonal agents (Xtandi, Zytiga) in the phase-3 PROFOUND study in second-line CRPC with certain genetic mutations:

https://www.businesswire.com/news/home/20200424005205/en

Lynparza is the only PARP inhibitor to show an OS benefit in this setting.

The PROFOUND study met its primary endpoint of radiographic PFS in Aug 2019, and the resulting NDA and MAA are currently under FDA and EMA review.

A trial of Lynparza in first-line CRPC is in progress with results expected in 2021.