AstraZeneca and Merck & Co., Inc., announced that the US Food and Drug Administration approved Lynparza for use in patients with a type of advanced breast cancer,
Dave Fredrickson, executive vice president, head of the oncology business Unit, AstraZeneca, said: “This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer. This is significant for breast cancer patients, as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”
The approval was based on data from the Phase III OlympiAD trial.
The use of the drug reduced the risk of disease progression or death by 42 percent – 7 vs 4.2 months).
The EndPoints biophara website stated reported that the FDA OK marked a victory for AstraZeneca CEO Pascal Soriot and a decision to focus on cancer drugs. Like many mature pharma companies, AstraZeneca has been dealing with a “patent cliff” as former blockbuster drugs lose protection to lower-cost generics.
Susan M. Domchek, executive director of the Basser Center for BRCA at the Abramson Cancer Center of the University of Pennsylvania, and a national leader on the OlympiAD trials, said: “Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat. While there is currently no cure for metastatic breast cancer, today’s approval offers a new, targeted option that may help to delay disease progression for these patients.”
This is the third approved use for Lynparza in the US, where it has been used to treat nearly 4,000 advanced ovarian cancer patients.
AstraZeneca andMerck are working together to deliver Lynparza as quickly as possible to more patients across multiple settings, including breast, ovarian, prostate and pancreatic cancers, a release stated.
AstraZeneca stock has been trading near 52-week highs, thanks to positive trails that overcome other disappointing findings.
The company, at last report, has 1,500 employees in Delaware.
Under the oncology collaboration with Merck, announced in July 2017, AstraZeneca is potentially eligible for more than $6 billion.
Following the new approval for Lynparza, AstraZeneca will receive $70 million.