Vismodegib and Enzalutamide Recommended for EU Approval

Zosia Chustecka

April 29, 2013

Two cancer drugs have inched closer to approval in Europe: vismodegib (Erivedge, Roche), for patients with advanced basal cell carcinoma; and enzalutamide (Xtandi, Astellas), for patients with metastatic castration-resistant prostate cancer who have progressed on or after docetaxel therapy.

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for both products at its recent April meeting. Final approval from the European Commission is anticipated shortly; it usually comes about 60 days after a CHMP recommendation.

Both products are already approved in the United States.

Vismodegib was approved in the United States in January 2012. It is an orally available agent that works as a Hedgehog inhibitor, and was hailed as "the greatest advance in therapy yet" for the treatment of basal cell carcinoma in an editorial (N Engl J Med. 2012;366:2225-2226) that accompanied the publication of 2 clinical trials (N Engl J Med. 2012;366: 2171-2179, 2180-2188) that showed "remarkable effects."

Enzalutamide was approved in the United States in August 2012. It is the first once-a-day oral drug that doesn't require concomitant steroids, and has been described as a "game changer" in the treatment of prostate cancer.

Two New Generic Cancer Drugs

At the same meeting, the CHPM also recommended 2 generic cancer drugs for approval; both are orally administered.

Generic capecitabine (manufactured by Sun Pharmaceuticals) will be indicated for use in colorectal, gastric, and breast cancer. Studies have shown that it is bioequivalent to Xeloda (Roche), which has been authorized in the European Union since February 2001.

Generic imatinib (manufactured by Accord Healthcare) is indicated for use in leukemia, and is bioequivalent to Gleevec (Novartis), which has been available in the European Union since November 2001.

In addition, the committee recommended approving an extension of the existing indication for lenalidomide (Revlimid, Celgene). This drug is already marketed for use in multiple myeloma; the indication has now been extended to include myelodysplastic syndrome.

The committee also noted that the shortage of the cancer drug liposomal doxorubicin (Caelyx) has been resolved. The drug is used in the treatment of breast and ovarian cancer, progressive multiple myeloma, and AIDS-related sarcoma.

Details of the CHMP decisions can be found on the European Medicines Agency Web site.


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