European regulators have approved a tablet formulation and new dosing regimen for AstraZeneca and MSD’s Lynparza to treat a wider range of patients with ovarian cancer.
Lynparza (olaparib) tablets have been cleared for use as a maintenance therapy for patients with platinum-sensitive relapsed (PSR) high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
The drug was originally approved in capsule formulation in Europe in 2015, but only for the one in five women with ovarian cancer who also had the BRCA mutation.
The decision to allow its use for maintenance therapy in all patients with PSR high-grade ovarian cancer, regardless of BRCA status, will significantly expand Lynparza’s reach.
Around 1,200 patients in the UK could now be eligible for treatment with the drug, according to AZ.
Also, regulators have approved a new dosing schedule that reduces the number of pills from eight capsules twice daily dosing to two tablets twice daily with or without food.
Clearance was based on two randomised trials, SOLO-2 and Study 19, which showed that the therapy cut the risk of disease progression or death for PRS ovarian cancer patients compared to placebo, by 70 percent and 65 percent, respectively.
“Clinical trials have shown that women with platinum-sensitive relapsed ovarian cancer can have better outcomes with olaparib compared to no active treatment. This is fantastic news for women with relapsed ovarian cancer regardless of BRCA mutation status,” said Dr Susanna Banerjee, consultant medical oncologist at the Royal Marsden NHS Trust.
Laurent Abuaf, country president, AstraZeneca UK, said the firm would now work closely with the NHS and NICE “to ensure that all appropriate ovarian cancer patients in the UK can benefit from this treatment”.
Ovarian cancer is a serious and life-threatening condition causing more than 4,000 deaths in the UK each year.