AstraZeneca's Lynparza candidate gets green light from FDA

Drugmaker AstraZeneca said on Monday that Lynparza candidate had been approved in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

AstraZeneca said on Monday that the approval by the Food and Drug Administration was based on results from its OlympiA Phase III trial, which demonstrated a "statistically significant and clinically meaningful improvement" in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers or death, by 42% versus a placebo.

AZN's Dave Fredrickson said: "This important approval gives early-stage breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today.

"Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients' lives versus placebo. These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza."

Separately, AstraZeneca said the Food and Drug Administration had issued a complete response letter regarding the supplemental Biologics License Application for its Fasenra candidate for patients with inadequately controlled chronic rhinosinusitis with nasal polyps.

The letter requested AZN supply additional clinical data, with the company now working closely with the FDA regarding next steps as it "remains committed to bringing Fasenra to patients". A second Phase III trial on the drug was ongoing.