AstraZeneca Announces Acceptance of Priority Review of Lynparza’s (olaparib) sNDA by FDA in Patients with BRAC-Mutated Advance Ovarian Cancer

 AstraZeneca Announces Acceptance of Priority Review of Lynparza’s (olaparib) sNDA by FDA in Patients with BRAC-Mutated Advance Ovarian Cancer

AstraZeneca Announces Acceptance of Priority Review of Lynparza’s (olaparib) sNDA by FDA in Patients with BRAC-Mutated Advance Ovarian Cancer

Shots:

  • The filling is based on results of P-III SOLO-1 study assessing Lynparza (300mg bid) vs PBO as a monothx in 391 newly-diagnosed patients with BRCA-m advanced ovarian cancer in ratio (2:1) for up to two years
  • The study showed improved results with reduction in the risk of disease progression or death by 70%, remained progression free @36 mos. (60% vs 27%). These results were presented at ESMO 2018
  • Lynparza is a novel inhibitor of PARP, approved for advance and metastatic breast cancer in Japan. Lynparza has received a PDUFA date in Q1’19 for BRAC-m advance ovarian cancer & is jointly developed by AstraZeneca & MSD

Click here to read full press release/ article | Ref: AstraZeneca| Image: USA Today

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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