February batch of EMA/CHMP new drug approval recommendations

Following its February meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for six novel new medicines, as well as two biosimilars.

The CHMP gave a positive opinion for Kimmtrak (tebentafusp), from Immunocore (Nasdaq: IMCR), for the treatment of uveal melanoma, a rare type of eye cancer. Kimmtrak was reviewed under the EMA’s accelerated assessment program. The CHMP based its recommendation on data from a randomized Phase III pivotal study and a supportive study. The study showed that Kimmtrak prolonged patients’ lives: the median overall survival was 21.7 months for patients receiving tebentafusp and 16 months for patients in the control group.

VBI Vaccines’ (Nasdaq: VBIV) PreHevbri (hepatitis B vaccine [recombinant, adsorbed]) was granted a positive opinion for the active immunization against hepatitis B virus infection.