Advisors to the European Medicines Agency have recommended against expanding the label on Roche's blockbuster Avastin to include an aggressive type of brain cancer.
The agency's Committee for Medicinal Products for Human Use has issued a negative opinion on Avastin (bevacizumab) for glioblastoma, in combination with radiation and temozolomide. Roche had presented data from one main trial of 921 patients and the CHMP noted that "although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours".
In addition, the CHMP noted, there was no improvement in overall survival so has decided that the benefits of Avastin for glioblastoma do not outweigh its risk. The drug is already approved in the USA and Japan for the disease.
Meantime, the CHMP has again recommended against approval of Novartis's heart failure drug serelaxin a week after the US Food and Drug Administration rejected the therapy.
The committee issued a negative opinion on the drug, which was tentatively called Reasanz, in January but Novartis asked for a re-examination. That has been completed and the treatment has been turned down again.
The CHMP noted that Novartis had only provided data from one Phase III study and the effectiveness of serelaxin had not been sufficiently demonstrated, although its safety seemed acceptable. Novartis said it will re-submit the drug with data from a second late-stage trial which will enroll over 6,300 patients but this is unlikely to report for a couple of years.
A re-examination of AB Science's Masiviera (masitinib) for certain types of advanced pancreatic cancer also failed to garner a recommendation for approval and as PharmaTimes reported last week, the CHMP reiterated its negative opinion on Teva/Active Biotech's multiple sclerosis pill Nerventra (laquinimod).