The latest set of opinions from the European Medicines Agency includes recommendations for cancer drug offerings from Pfizer and Takeda but a thumbs-down for a Celgene lymphoma drug.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Pfizer's Xalkori (crizotinib) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. Any approval will be conditional as the US drugs giant will need to submit further data from a recently-completed trial.
The CHMP has also recommended the granting of a conditional marketing authorisation for Takeda's Adcetris (brentuximab vedotin), licensed from Seattle Genetics, for the treatment of adults with relapsed or refractory CD30+ Hodgkin lymphoma. The agency has also backed Johnson & Johnson's Dacogen (decitabine), licensed from Astex, for acute myeloid leukaemia.
However, the CHMP has issued a negative opinion for Celgene's Istodax (romidepsin), intended for the treatment of peripheral T-cell lymphoma, saying the way a study was designed did not allow the committee to conclude on the clinical benefit of Istodax as it was not compared with any other treatment. It also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Celgene responded quickly and requested a re-examination, noting that during the regulatory review process, "it was acknowledged that romidepsin demonstrated anti-tumour activity". The data from the open-label mid-stage study the company submitted was sufficient to garner approval in the USA last year.