Regulatory Affairs

Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa

PBR Staff Writer Published 08 November 2017

Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).

Zelboraf has been approved for the first line treatment of patients with Erdheim-Chester disease (ECD) and who are positive for BRAF V600 mutation.

ECD is a rare and serious blood disease for which there was previously no approved treatment in the US.

The disease is characterized by the abnormal multiplication of histiocytes, which are certain white blood cells having a potential to intrude into normal tissues and organs in the body.

Zelboraf, which is a kinase inhibitor, functions by preventing certain enzymes that promote cell growth. Its approval was based on the findings of a phase 2 study, named as VE-BASKET which was held in 22 patients with BRAF-V600-mutation positive ECD.

Roche chief medical officer and global product development head Sandra Horning said: “We are committed to finding new ways to bring medicines to patients with high unmet need, and we are pleased that this innovative clinical trial helped identify Zelboraf for treatment of this rare disease.”

The FDA had earlier approved Zelboraf in 2011 for the treatment of certain patients with melanoma who are positive to the BRAF V600E mutation.

The other drug of Roche to get the regulatory nod is Alecensa (alectinib), which is for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Roche calls Alecensa to be a highly selective, CNS active, oral medicine.

Its approval is based on results from a phase 3 trial dubbed ALEX, which showed the drug to have reduced the risk of disease worsening or death significantly by 47% as compared to crizotinib.

Horning said: “In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain.”

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.