Immunocore Ready For First-Ever Launch After Kimmtrak’s US Approval
European Approval And Launch Also Expected Soon
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.
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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.
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.
Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.