Immunocore Working With EMA On Novel TCR Therapy Filing
While Immunocore is not giving details of what issues it still needs to address regarding its EU filing for tebentafusp, it said the drug is continuing to undergo an accelerated assessment by the CHMP.
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The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
The median pre-discount cost of Kimmtrak – the first approved TCR therapy and the first drug cleared for metastatic uveal melanoma – is $430,000, but the company says payers see the product’s value.