European approval for tablet formulation of Lynparza in ovarian cancer
pharmafile | May 8, 2018 | News story | Research and Development, Sales and Marketing | AstraZeneca, Cancer, EMA, Europe, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib) has been approved for use in Europe, it has emerged, with the EMA awarding authorisation to the drug as a maintenance therapy in the treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status.
The EU regulator based its decision on the results of two randomised clinical trials which demonstrated Lynparza’s ability to reduce the risk of disease progression or death associated with the condition. Specifically, Lynparza produced a progression-free survival PFS rate of 70% in germline platinum-sensitive relapsed ovarian cancer, and 65% in platinum-sensitive relapsed forms of the disease. The drug also displayed a median PFS of 30.2 months compared to just 5.5 months for placebo.
Significantly, in the final analysis of the second trial, with greater than five years of follow-up, Lynparza delayed time to first subsequent therapy or death by a median of 13.3 months compared to 6.7 months for placebo, while 13% of patients taking the drug remained progression-free and on therapy for five years or more years.
Lynparza was originally approved in Europe as a capsule in BRCA-mutated platinum-sensitive relapsed ovarian cancer; this new approval is for the drug’s tablet formulation, which reduces dosing down to two tablets twice daily, from eight capsules twice daily.
“Until recently, beyond chemotherapy, there have been limited treatments for women with relapsed ovarian cancer. The EMA approval gives many more ovarian cancer patients the opportunity to benefit from olaparib; previously it was only available for women with a mutation in BRCA genes,” explained Dr Susanna Banerjee, Consultant Medical Oncologist at Royal Marsden NHS Foundation Trust. “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.”
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, added: “With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”
Matt Fellows
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