Merck KGaA, Pfizer's Bavencio recommended for approval by EMA panel for Merkel cell carcinoma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion backing approval of Merck KGaA and Pfizer's anti-PD-L1 antibody Bavencio (avelumab) as monotherapy for the treatment of adults with metastatic Merkel cell carcinoma (MCC). "We welcome the CHMP's recommendation, as there are currently no approved treatments in Europe for this type of skin cancer," remarked Luciano Rossetti, global head of R&D at Merck. 

Merck and Pfizer noted that the positive CHMP opinion was supported by safety and efficacy data from the mid-stage JAVELIN Merkel 200 trial, which is split into two parts, with the first part involving 88 patients with metastatic MCC whose disease worsened after at least one round of chemotherapy. The second part, which enrolment is ongoing, included 39 treatment-naive patients with metastatic MCC at the time of the data cut-off. In study results released last year, Bavencio produced an overall response rate of 31.8 percent, in addition to a manageable safety profile. 

The drugmakers noted that the European Commission is expected to issue a final decision regarding the approval of Bavencio in the current quarter. The therapy has been awarded orphan drug status by the EMA (for related analysis, read ViewPoints: Broad focus of PD-(L)1 inhibitors enhances the dominance of oncology over Orphan drug landscape).

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Bavencio was cleared earlier this year by the FDA for the treatment of adults and children aged 12 and older with metastatic MCC. The therapy had been granted breakthrough therapy, fast track and orphan drug designation, as well as priority review in MCC by the US regulator. 

Merck and Pfizer entered into an agreement in 2014 potentially worth more than $2.8 billion to jointly develop and commercialise Bavencio for multiple cancer indications. Merck estimated that the drug and others in its pipeline will generate about 2 billion euros in annual sales by 2022. 

For related analysis, see Spotlight On Interview: Merck KGaA Healthcare CEO Belén Garijo – reformed R&D strategy beginning to pay dividends.

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