Personalised cancer immunotherapy granted fast track designation
The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
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The FDA has granted fast track designation for Evaxion’s personalised cancer vaccine in combination Keytruda® for patients with metastatic melanoma.
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
The combination of motixafortide, KEYTRUDA® and chemotherapy met all trial endpoints, including increasing overall and progression free survival.
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
Novartis, Merck and Allergan have joined numerous other pharmaceutical companies by increasing the price of certain drugs since the start of 2020.
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.