Regulatory Affairs

Roche secures cancer drug approvals in Europe and US

PBR Staff Writer Published 22 December 2017

Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.

The European Commission has approved Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer, while the US Food and Drug Administration (FDA) approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence.

The marketing authorization from the EC for Alecensa was driven by the findings of the phase 3 ALEX study in which the lung cancer drug reduced the risk of disease worsening or death by 53% in comparison to crizotinib.

The ALEX study evaluated the efficacy and safety of Alecensa against crizotinib, which is an approved drug for NSCLC in the US and other countries.

The late-stage trial was carried out in 303 patients with ALK-positive NSCLC whose tumours were characterized as ALK-positive and who were previously not treated for their condition.

Alecensa, which is a selective, CNS active oral drug, was also shown to have brought down the risk of tumours spreading to, or growing in the brain or central nervous system (CNS) by 84% in comparison to crizotinib.

Roche chief medical officer and global product development head Sandra Horning said: “Many ALK-positive lung cancer patients see their disease progress within a year on current treatments.

“The EU approval of Alecensa heralds a new era for these patients, who now have a treatment option available that halves the risk of disease progression compared with the previous standard of care, crizotinib and is also highly effective against brain metastases.”

In another development, Roche’s Perjeta (pertuzumab) has been approved in the US for post surgery treatment of a specific type of early breast cancer (eBC).

The approval from the US Food and Drug Administration (FDA) is for Perjeta in combination with Herceptin (trastuzumab) and chemotherapy for adjuvant treatment of HER2-positive eBC at high risk of recurrence.

The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive eBC at high risk of recurrence is based on results of the phase III APHINITY study. 

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