Roche’s big-selling cancer drug Avastin should not be approved for use in glioblastoma – a form of brain cancer – according to the EU regulator.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the use of Avastin (bevacizumab) alongside radiation therapy and temozolomide in glioblastoma – the current standard of care – saying the clinical data submitted by Roche to support its application did not pass muster.
The CHMP’s latest round of opinions included recommendations for six new medicines. The negative decision for Avastin comes despite the fact that the drug has already been approved in both the US and Japan to treat glioblastoma.
Roche’s largest study – which enrolled more than 900 patients – showed that Avastin was able to improve progression-free survival (PFS) when added to the background treatment, but the CHMP concluded that this finding “could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours.”
The panel was also unhappy that there was no improvement in overall survival (OS), concluding that on balance the benefits of the drug did not outweigh its risks in this form of brain cancer, which constitutes 15 per cent of all nervous system tumours and commonly occurs in adults aged 45 to 70 years.
Avastin has been on the market since 2005 and is already approved to treat several malignancies, including colorectal, breast, lung, kidney and ovarian cancers. It is Roche’s second biggest-selling drug, bringing in sales of 6.25bn Swiss francs (around $7bn) last year.
At its meeting last week the CHMP also confirmed its negative opinion – after a re-examination – on AB Science’s Masiviera (masitinib) for certain types of advanced pancreatic cancer and Novartis’ heart failure drug Reasanz (serelaxin). Both drugs were originally rejected earlier this year.
It also reported that Servier had elected to withdraw its application to extend the indications of its osteoporosis therapy Protelos/Osser (strontium ranelate) to include osteoarthritis of the knee and hip.
The company had filed a 1,600-patient study in support of the application but withdrew it after the CHMP indicated the dossier was likely not approvable without further evidence of the drug’s benefits in osteoarthritis.