EMA gives positive opinion on Keytruda as adjuvant therapy

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/PeopleImages)
(Image: Getty/PeopleImages)

Related tags: Ema, positive opinion, Keytruda, Clinical trial, Oncology, marketing authorization

MSD announced that the EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in recommending the approval of MSD’s (known as Merck in North America) Keytruda, an anti-PD-1 therapy, as an adjuvant therapy in the treatment of patients with melanoma with lymph node involvement.

The positive opinion was informed by data from a Phase III trial, conducted in collaboration with the European Organization for Research and Treatment of Cancer, which demonstrated a significant improvement in recurrence-free survival. 

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected at the end of 2018.

According to MSD, the incidence of melanoma has been increasing over the past four decades. It is estimated that in 2018 there will be more than 287,000 new cases of melanoma. In Europe, the five-year survival rate for advanced or metastatic melanoma is estimated to be between 5% and 22%.

Pamela Eisele, global communications director at MSD, told us that the company will continue to investigate Keytruda in the adjuvant setting, and is testing in the neoadjuvant setting as well.

Phase III neoadjuvant and adjuvant studies with Keytruda are underway in breast, lung, gastric, and kidney tumor types, we were told.

“We expect a final decision on our application with the EMA in the fourth quarter of 2018 and with the US Food and Drug Administration in February 2019,”​ said Eisele.

Related topics: Markets & Regulations, Emerging Markets

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