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Maintenance OK boosts AstraZeneca’s Lynparza in Europe

New pill formulation also helps AZ and MSD against competitors in PARP class

AZ

AstraZeneca and MSD’s PARP inhibitor Lynparza has been approved for maintenance therapy in ovarian cancer in Europe, giving the drug a green light for the indication on both sides of the Atlantic.

Lynparza (olaparib) can now be used in Europe to prevent relapse in patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, regardless of BRCA status, and critically gets the green light for a new tablet formulation that reduces the pill burden compared to the earlier capsule version.

The drug is the second to be approved for use in this setting after Tesaro’s PARP drug Zejula (niraparib), and ahead of another rival – Clovis Oncology’s Rubraca (rucaparib) – for which conditional approval was backed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in March for a slightly different indication.

Rubraca’s proposed EU label indicates it can be used in women in the later stages of epithelial ovarian, fallopian tube or primary peritoneal cancer who have received two or more lines of platinum chemotherapy, although the company recently started an early-access programme in Europe for the drug both for third-line treatment and maintenance of recurrent ovarian cancer.

In the US the situation is even more competitive, with all three drugs converging around second-line maintenance therapy. Lynparza has been approved for maintenance there since August of last year, getting the go-ahead a few months after Zejula and a few months ahead of Rubraca, which got its FDA okay last month. All the drugs were approved on the back of progression-free survival (PFS) data.

As the first PARP inhibitor to reach the market, AZ is emphasising the longstanding heritage of the drug, with more than five years’ efficacy and safety follow-up data, as it tries to stay ahead of the competition.

With the PARP inhibitors looking increasingly interchangeable from a clinical perspective, AZ enlisted the aid of MSD (known as Merck & Co in the US and Canada) to provide co-marketing muscle. That is another key element in its defence of the brand, as is the potential to combine Lynparza with MSD’s big-selling immuno-oncology drug Keytruda (pembrolizumab).

Roy Baynes, chief medical officer for MSD Research Labs, said the approval is “an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease.”

AZ and Merck’s drug is still in front in terms of sales, bringing in $218m last year, compared to $109m for Zejula and $55m for Rubraca.

Since then, Lynparza has also been approved for BRCA-mutated HER2-negative metastatic breast cancer, and according to comments by MSD in its first-quarter results the launch is progressing well following its January go-ahead from the FDA. That indication is also under review by the EMA.

Article by
Phil Taylor

9th May 2018

From: Regulatory

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