Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA

Heads Up Tesaro: AstraZeneca, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA August 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WILMINGTON, Del. – AstraZeneca and new partner Merck received some good news Thursday when the U.S. Food and Drug Administration approved expanded use for the PARP inhibitor Lynparza as a maintenance treatment women with certain kinds of ovarian cancer.

The FDA said Lynparza (olaparib) can now be used as ongoing treatment for adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. In addition to its expanded use, the FDA also greenlit a new tablet form of Lynparza that reduces the number of pills patients take each day. In the tablet form, patients will take two tablets twice daily, as opposed to the eight capsules patients took twice per day.

Lynparza was first approved by the FDA in 2014 in the capsule formulation. It was the first PARP inhibitor approved by the FDA. PARP stands for poly ADP ribose polymerase, which is an enzyme many cancer cells are more dependent upon than regular, healthy cells are.

“Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients,” AstraZeneca Chief Medical Officer Sean Bohen said in a statement.

Richard Penson, clinical director of medical gynecologic oncology at Massachusetts General Hospital Cancer Center and the primary investigator in the Lynparza clinical trial, said the FDA approval validates the research showing Lynparza is an effective maintenance treatment for ovarian cancer. He said additional options for patients regardless of BRCA status will ensure doctors can find the best treatment for them.

Earlier this month, AstraZeneca and Merck struck a research and development agreement worth up to $8.5 billion. That agreement includes testing Lynparza in combination with PD-1 inhibitors manufactured by both companies. Lynparza, which has been approved in the United States for the treatment of one type of ovarian cancer, will be combined with AstraZeneca’s Imfrinzi and Merck’s Keytruda. The companies said they will work independently to combine Lynparza with their own PD-1 inhibitors, but will work together in combination with other drugs. Additionally, the companies will work together to test Lynparza in combinations with other undisclosed drugs.

Roger M. Perlmutter, president of Merck Research Laboratories, called the FDA’s decision a “significant first regulatory event in our collaboration with AstraZeneca.” The new indication for Lynparza was certainly pleasing to Merck considering the amount of money it paid to AstraZeneca to partner on the drug.

The new indication means Lynparza can directly challenge Tesaro’s Zejula, which was the first PARP inhibitor that received approval in the United States for the maintenance treatment of women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status. Since the FDA’s announcement, shares of Tesaro have declined from $115.70 to this morning’s price of $108.58 as of 10 a.m.

The FDA granted the new indications to Lynparza based on the Phase III SOLO-2 study that showed Lynparza delayed the recurrence of ovarian cancer by more than two years compared to placebo. The study demonstrated a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer. In gBRCA-mutated patients, Lynparza demonstrated a 70 percent reduced risk of disease progression or death and improved median progression-free survival (PFS) to 19.1 months for Lynparza patients vs. 5.5 months for placebo.

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