- AstraZeneca plc secured a key U.S. approval for its cancer drug Lynparza, broadening the PARP inhibitor's label to cover earlier treatment of ovarian cancer just as new competition has begun to bite into the British drugmaker's market share.
- Lynparza is now approved as a maintenance treatment for ovarian cancer patients who are in response to platinum-based chemotherapy, regardless of BRCA-mutation status. Previously, the drug had only been OK'd for use in third-line or later treatment of patients with BRCA-mutated ovarian cancers, a much narrower slice of the market.
- An expanded label will help Lynparza stave off emerging competition from Tesaro, Inc.'s Zejula (niraparib) and Clovis Oncology, Inc.'s Rubraca (rucaparib), two PARP inhibitors approved within the past 10 months.
Lynparza (olaparib)'s expanded label is good news for Merck & Co., which last month inked a major cancer pact with AstraZeneca centered on the PARP inhibitor.
Under the deal, AstraZeneca gave up rights to 50% of gross profits from sale of Lynparza in exchange for $1.6 billion upfront plus another $6.9 billion in license options, regulatory and sales milestones. The two pharma companies will jointly commercialize Lynparza, but will independently test the drug in combination with their respective checkpoint inhibitors, Imfinzi (durvalumab) and Keytruda (pembrolizumab).
Combining forces with Merck, while coming at the cost of losing half of Lynparza's sales, should help ensure Lynparza stays the leading PARP inhibitor. And the deal could open up new markets through combinations with Keytruda that previously wouldn't have been accessible for AstraZeneca.
At least, that's the thinking. AstraZeneca announced the deal simultaneously with disclosing a major setback in its closely watched MYSTIC study of Imfinzi in first-line lung cancer. A win there would have done much to help AstraZeneca catch immuno-oncology leaders on its own. But the negative results diminish AstraZeneca's competitiveness in a field that has accelerated quickly.
In that context, building out the market for Lynparza as a top-tier oncology asset becomes even more important. In the second quarter, Lynparza sales in the U.S. totaled only $50 million, down 19% from the same period a year previous due to competition from Zejula and Rubraca.
Zejula, in particular, quickly captured a leading market share in the PARP inhibitor market with more than 1,500 patient starts during the quarter.
Securing an FDA OK for Lynparza as a maintenance therapy in second-line will give AstraZeneca and Merck the opportunity to significantly grow sales further. Cowen and Co. analysts predict Lynparza revenues to reach $170 million this year, $580 million next year and $1.8 billion by 2022.
AstraZeneca also secured approval Thursday for use of Lynparza tablets, which simplify administration of the drug to two tablets twice daily instead of eight capsules twice daily.