EMA Advisory Committee Recommends Additional Uses for Two Roche Cancer Drugs

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended for approval additional uses for two Roche cancer drugs. 

In the first, the CHMP has adopted a positive opinion for Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance as a new treatment for people with follicular lymphoma who did not respond to, or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen. Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin lymphoma.

Gazyvaro is marketed as Gazyva outside of the European Union and Switzerland. In February 2016, Gazyva received approval by the US Food and Drug Administration in combination with bendamustine followed by Gazyva monotherapy as a treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment.

Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyva/Gazyvaro is currently approved in more than 70 countries in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukemia.

In other news, the CHMP has issued a positive opinion for the use of Roche’s Avastin (bevacizumab) in combination with Roche’s Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer.

Avastin was initially approved in the United States for advanced colorectal cancer in 2004. It is now approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and platinum-resistant, recurrent ovarian cancer. In addition, Avastin is approved in over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to inhibit EGFR, a protein involved in the growth and development of cancers. Tarceva is developed and commercialized by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan, and Roche in the rest of the world.

Source: Roche (Gazyvaro)  and Roche (Avastin)

Leave a Reply

Your email address will not be published. Required fields are marked *