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AZ and MSD secure three bits of good news on key drug

Published on 18/08/17 at 09:51am

It was a case of three-in-one bits of good news for AstraZeneca and MSD, after the FDA boosted the newly formed Lynparza partnership with an expanded indication and new formulation approval.

In full, the news on the drug included:

  • A new indication for the treatment of patients recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status
  • The new use of Lynparza tablets, which means that patients can now take two tablets twice daily instead of the capsule formulation taken twice daily in batches of eight
  • Lynparza tablets have been confirmed as approved for use in adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy – confirming the accelerated approval already received in this indication

This solid series of approvals means that the collaboration between AZ and MSD is off to a winning start. Only last month, the same day that Mystic trial results were found to be disastrous for the company, AZ announced that it had signed an $8.5 billion deal with MSD for half of the rights to the drug.

The deal makes sense for both companies, with MSD seeking success in combination pathways for Keytruda and means that AZ can ride the coattails of any success from a leading immunotherapy treatment.

Sean Bohen, Executive Vice President, Chief Medical Officer, AstraZeneca said: “Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women. Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with MSD, which aims to further increase the number of treatment options available to patients.”

It is now reported that AZ and MSD are looking to take the drug forward to seek approval in indications in breast cancer later this year.

Ben Hargreaves

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