EMA recommends approval of AZ's ovarian cancer drug
- AstraZeneca's Lynparza (olaparib) has been recommended for approval for treatment of BRCA-mutated ovarian cancer by the European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP).
- Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that has been developed by AZ to be used in patients with ovarian cancer who have had either complete or partial response to platinum-based chemotherapy.
- In clinical studies, Lynparza treatment in women with ovarian cancer who met the criteria for treatment experienced prolonged progression-free survival compared with placebo.
It became clear at the end of May that Pfizer's rumored acquisition of AstraZeneca (AZ) would most likely not be happening. AZ, as a company, demonstrated its determination to maintain its independence by moving forward and aggressively developing its pipeline--and based on today's news, this strategy is yielding results.
In addition to the CHMP approval recommendation, Lynparza is up for approval in the U.S. Although the FDA requested that the company complete another study to confirm the drug's benefit, the new PDUFA date is January 3, 2015.
- Pharmaceutical Business Review EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza