Merck KGaA and Pfizer have won FDA breakthrough therapy designation for avelumab for the treatment of metastic Merkel cell carcinoma (MCC).
The designation is based on data from the phase II study – Javelin Merkel 200 – which assessed the safety and efficacy of avelumab in patients with MCC whose disease had progressed after at least one prior chemotherapy regimen.
The designation represents a significant milestone and has the potential to speed up the development of avelumab for metastic MCC patients.
Luciano Rossetti, global head of research and development at Merck KGaA, said: “Metastic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients.
“With this breakthrough therapy designation, we are one step close to our goal of making a significant different to patients living with difficult-to-treat cancers.
“In less than two months, the alliance between Merck KGaA and Pfizer has achieved its third regulatory milestone for avelumab, including orphan drug designation and fast track designation granted in September and October.”
Avelumab is a fully human anti-PD-L1 IgG1 monoclonal antibody, thought to enable the activation of T-cells and the adaptive immune system. MCC has gained a lot of attention in recent months, however Merck KGaA believes avelumab can also become one of the first immunotherapies to be approved for ovarian, gastric, bladder and renal cancers.
Merck KGaA and Pfizer announced their alliance to develop avelumab in November 2014, and if the drug is eventually approved it would certainly justify the $850m Pfizer handed over to buy into Merck KGaA’s immunotherapy pipeline.