AstraZeneca Hits And Misses: Trio Of EU Label Expansions But US Lynparza Review Delayed
The major has won two positive CHMP opinions and one EU approval for meaningful label expansions across its oncology and cardiology franchises, but a delayed US review for prostate cancer drug Lynparza has put a spanner in the works.
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AstraZeneca’s Lynparza: US FDA Frowns Upon ‘All Comers’ Indication In First-Line Prostate Cancer
Efficacy in PROpel study was driven by the small percentage of patients with tumor BRCA mutations, agency says, raising concerns that olaparib may amount to a ‘toxic placebo’ in those without the mutation; Oncology Drugs Advisory Committee will consider whether new indication in metastatic castration-resistant prostate cancer should be restricted by mutation status.
J&J Wins EU Nod For Akeega To Go Up Against AZ/MSD’s Lynparza In First-Line mCRPC
Akeega, a combination of GSK’s PAPR inhibitor Zejula and J&J’s antiandrogenic drug Zytiga, has won a positive opinion from the CHMP in a lucrative first-line prostate cancer setting, hot on the heels of a broader approval for AstraZeneca’s blockbuster Lynparza.
Natco Continues Para IV Charge With $1.2bn Lynparza, FTF ‘Possible’
Indian firm Natco is continuing to build its US pipeline and ex-India geographic presence, the company’s management told investors, in the wake of announcing a major paragraph IV patent challenge opportunity.