“The successful outcome of the European Mutual Recognition Procedure is the result of excellent teamwork by both RPR and Guilford,” said Max Talbott, RPR Worldwide Vice President, Regulatory Affairs. “We look forward to making Gliadel available in Europe as an important new treatment option for patients with recurrent glioblastoma multiforme, once any required pricing and/or labeling approvals are obtained.”
Gliadel will be used as an adjunct to surgery in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated. Glioblastoma multiforme is one of the most common and rapidly fatal forms of malignant brain cancer.
In this European Mutual Recognition Procedure, France acted as the Reference Member State. The first marketing authorization of Gliadel in Europe was granted in France in December 1998.
As the first significant new local treatment for brain cancer in over 20 years, Gliadel is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, minimizing drug exposure to other areas of the body. Gliadel is a biodegradable polymer wafer that is implanted in the cavity created when a brain tumor is surgically removed. As the wafer erodes in the brain, it releases the cancer chemotherapeutic drug, carmustine (BCNU), directly to the tumor site in high concentrations over an extended period of time.
Gliadel was first approved by the FDA in the fall of 1996 for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated. In 1996, Guilford and Rhone-Poulenc Rorer (RPR) entered into an agreement granting RPR worldwide marketing and distribution rights (currently excluding Scandinavia and Japan), for Gliadel.
“We are pleased by RPR’s commitment to expand the market for Gliadel, both in Europe and in other international markets,” remarked Craig R. Smith, President and Chief Executive Officer of Guilford. “Their commitment to the field of oncology is well established, and we are very pleased by their ability to secure regulatory approval for Gliadel throughout Europe.”
Marketing authorization is the first of several steps necessary to market Gliadel. Additional labeling and pricing approvals are required before Gliadel may be launched in most European and international markets. If RPR obtains these European approvals for the current labeled indication, Guilford is eligible to receive milestone payments.
Gliadel offers an important treatment option for neurosurgeons and complements other standard therapies for brain cancer. In a randomized clinical trial, Gliadel was shown to prolong survival in patients with glioblastoma multiforme for whom surgical resection is indicated. In this multicenter study involving 145 patients with recurrent glioblastoma multiforme, Gliadel increased six month survival from 36 percent with placebo to 56 percent with Gliadel.
The spectrum of adverse events observed in patients with recurrent malignant glioma who received Gliadel or placebo was consistent with that encountered in patients undergoing craniotomy for malignant gliomas. Clinically relevant side effects that were more common with Gliadel versus placebo included healing abnormalities, brain edema, and intracranial infections. Seizures that occurred in patients receiving Gliadel had a much earlier onset, although the incidence of seizures was the same in the placebo and Gliadel groups