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CHMP backs AZ’s Lynparza for ovarian cancer maintenance

Studies show that the drug reduced risk of disease progression

AZ

AstraZeneca and partner Merck & Co have moved a step closer to a second-line maintenance indication for PARP inhibitor Lynparza in ovarian cancer in the EU after a positive opinion from the CHMP.

The new indication - which has already been approved in the US - could help AZ and Merck (known as MSD in Europe) maintain their first-mover advantage in the PARP inhibitor category in the face of competition from newer market entrants Rubraca (rucaparib) from Clovis Oncology and Johnson & Johnson/Tesaro’s Zejula (niraparib).

The CHMP has backed the new easier-to-take tablet formulation of Lynparza (olaparib) for use as maintenance therapy in women with platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

The committee’s recommendation is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.

Sean Bohen, head of global medicines development and chief medical officer at AstraZeneca, said that trials "show that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer".

Lynparza can be used in these patients regardless of the patient’s BRCA status, said AZ and Merck. That’s an important point because Zejula seems to have been gaining ground in the marketplace in part because its label did not require ovarian cancer patients to be tested for their BRCA status.

Zejula was approved for ovarian cancer maintenance last year, while Rubraca is also in late-stage development for this indication setting up a three-way battle. In the meantime, AZ and Merck have been trying to stay ahead of their rivals with new indications for Lynparza in breast cancer.

AZ enlisted Merck’s aid in promoting Lynparza last year in a $8.5bn cancer alliance, and adding that marketing muscle is being viewed increasingly as a canny move as competition in the PARP inhibitor market heats up. Sales of Lynparza grew by a third to $297m last year and rose nearly two-thirds in the fourth quarter to $100m. Tesaro and Clovis will report fourth quarter results this week.

Article by
Phil Taylor

26th February 2018

From: Regulatory

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