Drug Development

Step aside AstraZeneca, Pfizer/Merck KGaA jump ahead, getting a speedy review for their checkpoint rival avelumab

Luciano Rossetti, Merck KGaA

Luciano Rossetti, Merck KGaA

Now it’s Pfizer’s turn to jump into the hotly contested checkpoint market.

The pharma giant and its partner Merck KGaA say that the FDA has accepted their first BLA for avelumab, with regulators promising a speedy review for this latest checkpoint inhibitor — likely relegating AstraZeneca to an embarrassing fifth place finish for its laggard.

Pfizer and the German Merck will be taking a shot at first mover advantage in metastatic Merkel cell carcinoma, where investigators have tracked positive data in the JAVELIN Merkel 200 study. The drug is currently in 30 clinical programs as the two players look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.

The collaborators were enthusiastic about the FDA’s decision to handle this under its priority review program, cutting down the process from 10 months to 6.

This drug holds special meaning for both players. Merck KGaA has undergone repeated R&D organizations over the years, fruitlessly seeking a major new approval after going for more than a decade without adding a new blockbuster to its portfolio. For Pfizer, which paid a record $850 million upfront to partner on the drug, adding $2 billion in milestones, avelumab offers a chance to build its presence in the cancer mark, where it has achieved its greatest successes. Pfizer recently paid $14 billion to acquire Medivation, gaining a major drug for prostate cancer as well as a late-stage PARP program.

Their gain is AstraZeneca’s loss. The pharma rival has been trying to play catchup with durvalumab, which will now join the lineup as the fifth prospective checkpoint, behind Merck, Bristol-Myers Squibb, Roche and this new prospect. AstraZeneca recently canceled a mid-stage effort to gain an accelerated approval for durvalumab as a monotherapy. It’s now sticking with a combo approach, though the company also had to endure a brief partial hold in head and neck cancers so investigators could check out problems with bleeding among patients.

“There are currently no approved treatment options for metastatic MCC, and we are committed to working with the FDA to potentially bring the first approved cancer immunotherapy to patients with this aggressive disease,” said Merck KGaA R&D chief Luciano Rossetti.


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