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Lynparza approval sets up tighter bout with PARP rivals

US regulator gives AZ the go-ahead for a new maintenance indication and formulation

FDA

AstraZeneca and new partner Merck & Co have won FDA approval for a new indication for Lynparza, plus a new formulation that will make the drug more competitive.

The US regulator gave the go-ahead to a new version of the PARP inhibitor that can be dosed as two tablets twice a day, rather than the prior regimen that required eight capsules to be given twice-daily, as a maintenance therapy for women with platinum-sensitive ovarian cancer regardless of whether the tumour has a BRCA mutation.

The FDA has also finalised an earlier conditional approval of Lynparza (olaparib) in BRCA-positive patients who have been treated with three or more lines of chemotherapy.

The new maintenance indication and formulation - which extends to women with fallopian tube and primary peritoneal cancers as well - gives Lynparza a more competitive footing with its rivals in the PARP inhibitor category in the US, and particularly Tesaro's Zejula (niraparib) which was approved as a maintenance therapy in March on the back of strong clinical data.

Zejula was approved without any need to test for BRCA mutations, which are seen in around a third of ovarian cancer patients, and Lynparza's new approval means it can now also be prescribed without a need for biomarker testing beforehand. That nullifies a big competitive edge for Tesaro's drug that were a factor in analysts predicting rapid sales gains to $1bn-plus.

Another PARP inhibitor - Clovis Oncology's Rubraca (rucaparib) - was approved last December for use in women with advanced ovarian cancer who have been treated with two or more chemotherapies and have BRCA-positive tumours. Clovis is however carrying out a phase III trial called ARIEL3 that reported positive results in June and could extend its use to include non-BRCA patients.

AZ has just enhanced its position in the three-way battle by joining forces with Merck & Co in an $8.5bn alliance that will put Merck's marketing muscle behind the PARP inhibitor, and also see PD-1 blocker Keytruda (pembrolizumab) tested alongside Lynparza in a wide range of tumour types, including breast cancer.

Merck's head of R&D Roger Perlmutter said the new approvals were "a significant first regulatory event" in its collaboration with AZ, which has become more important for the latter since it reported disappointing results with its immuno-oncology combination in the MYSTIC trial.

Article by
Phil Taylor

21st August 2017

From: Regulatory

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