CHMP recommends marketing authorisation of Lynparza for ovarian cancer

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the marketing authorisation of Lynparza (olaparib) tablets for patients with platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor, which works by targeting tumour DNA damage response (DDR) pathway deficiencies to destroy cancer cells rather than healthy cells. This recommendation covers the tablets for use as maintenance therapy regardless of a patient’s BRCA status.

“We welcome this positive opinion based upon data which indicate the potential impact for Lynparza as maintenance therapy for women with platinum-sensitive relapsed ovarian cancer,” said Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories. “We look forward to our continued work with AstraZeneca to bring Lynparza to patients in the EU.”

The positive opinion was based on the results of two randomised trials, demonstrating the efficacy of Lynparza compared to placebo in the reducing disease progression or number of deaths for platinum-sensitive relapsed patients.

“The data 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, irrespective of their BRCA status,” explained Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca. “It also offers a well-characterised safety and tolerability profile, which is critical to help enable patients to stay on treatment.”

Lynparza is currently being investigated in a range of DDR-deficient tumour types and represents the foundation of AstraZeneca’s portfolio of compounds targeting DDR mechanisms in cancer cells. In July last year (2017), Merck and AstraZeneca announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza for multiple cancer types.