WASHINGTON _ The FDA's Oncologic DrugsAdvisory Committee (ODAC) on Tuesday recommendedapproval for Taxotere, Rhone-Poulenc Rorer Inc.'ssecond-line therapy for patients with advanced breastcancer.
The committee said Taxotere should be approved for usein patients who have failed first-line anthracyclinetherapy unless they have abnormal liver function which isassociated with higher toxic effects.
Collegeville, Pa.-based Rhone-Poulenc's stock(NYSE:RPR) closed at $47.84, up $1.09 per share.
Committee approval enables the company to beginbuilding its "oncology franchise" as the company seeksregulatory approval to market Taxotere to treat severaltypes of cancers, said Gary Shearman, Rhone-Poulencsenior vice president for pharmaceutical drugdevelopment.
ODAC rejected Rhone-Poulenc's first application forTaxotere last December (See BioWorld Today, Dec. 14,1994, p. 1) after several members raised concerns aboutthe toxicity of the drug, especially the side effects of fluidretention.
Taxotere was the third breast cancer therapy approved byODAC at its two-day meeting this week. On Monday itapproved two hormonal therapies for advanced breastcancer in post-menopausal women. The "greatimportance" of the three approvals was hailed by AmyLanger, executive director of the National Alliance ofBreast Cancer Organizations, of Washington, who told apress conference that women with breast cancer will"demand and expect a wider range of treatment options."
The presence of patient advocates with advancedmetastatic breast cancer was often noted during theadvisory committee's deliberations on Taxotere. Severalmembers praised the advocates' commitment toparticipate in clinical trials and to make the interests ofpatients known to the committee. Langer said that the"patients had profoundly influenced the proceedings bydemanding change."
She also promised that breast cancer patients will workwith drug makers and FDA officials to develop yet moretherapies. "We need and want to work closely withpharmaceutical firms and the government to develop thebest range of treatment options."
The indication for which Rhone-Poulenc sought approvalthis week is the first in a long line of Taxotereindications, the company said. The pending NDA wasindicated only for metastatic breast cancer patients whohave progressed during anthracycline therapy or haverelapsed. About 46,000 women are diagnosed annuallywith metastatic breast cancer.
In the next few months the company will seek indicationsfor Taxotere's use in small cell lung cancer, ovariancancer and head and neck malignancies. The companycites recent data showing that Taxotere has the highestever reported anti-tumor activity of 56 percent inadvanced breast cancer patients resistant to anthracycline.
Taxotere already is approved for use in Mexico, Canada,South Africa, Uruguay and Brazil for breast and non-small cell lung cancer. Applications are pending inAustralia and the European Community.
The company also intends to compete head-on with NewYork-based Bristol-Myers Squibb Co.'s Taxol,chemically similar to Taxotere. Taxol is the most recentlyapproved therapy for advanced breast cancer. (SeeBioWorld Today, Dec. 14, 1994, p. 1.)
Six members of the advisory committee voted torecommend approval of Taxotere with panel chairmanPaul Bunn, director of the University of Colorado CancerCenter in Denver, abstaining. He criticized Rhone-Poulenc's application for not providing sufficient detailsabout treatment outcomes with a lower dose than the 100mg/m2 contained in the indication sought by themanufacturer. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.