AMERSHAM’s METASTRON (STRONTIUM-89) APPROVED FOR BONE PAIN RELIEF
Executive Summary
AMERSHAM's METASTRON (STRONTIUM-89) APPROVED FOR BONE PAIN RELIEF in cancer patients with painful skeletal metastases on June 18. Metastron is "not indicated for use in patients with cancer not involving bone," the precautions section of approved labeling states. The injectable radiopharmaceutical was designated a "1P" approval (priority review) by FDA. The NDA (20-135) was filed on Nov. 30, 1990 by Medi-Physics, Amersham's U.S. radiopharmacy unit based in Arlington Heights, Ill. FDA sent the firm refusal to file and refusal to file over protest letters dated Feb. 4, 1991 and Sept. 11, 1991 before commencing with its review of the new molecular entity. Zeneca and Amersham will comarket Metastron under a worldwide agreement formed at the close of Amersham's fiscal year (ended March 31). Zeneca plans to market the drug initially to physicians who treat prostate cancer patients, the firm said in a May 12 public offering prospectus. Amersham's responsibilities under the deal include the manufacture and distribution of the drug, Zeneca said. The recommended dose of the radiopharmaceutical is 148 megabecquerels (4 mu Ci), or, alternatively 1.5 to 2.2 MBq (40-60 mu Ci)/kg body weight, given as a one- to two-minute I.V. injection. Repeated doses "should be based on an individual patient's response to therapy, current symptoms, and hematological status, and are generally not recommended at intervals of less than 90 days," labeling counsels. "In view of the delayed onset of pain relief, typically 7 to 20 days post-injection, administration of Metastron to patients with very short life expectancy is not recommended," the precautions section adds. The warning section of approved labeling states that Metastron use in patients "with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs the risks. Bone marrow toxicity is to be expected following the administration of Metastron, particularly white blood cells and platelets. The extent of toxicity is variable." Labeling adds that "verification of dose and patient identification is necessary prior to administration because Metastron delivers a relatively high dose of radioactivity." Metastron has been approved in 11 countries for the relief of bone pain associated with prostate cancer, Amersham reported in a June 9 financial release. In the U.K. and France, Metastron's indication has been extended to cover use as an adjunct or alternative to radiotherapy, the U.K.-based firm added. Cytogen is also developing a radiopharmaceutical for the alleviation of bone pain associated with metastatic cancer. The company acquired Samarium-153 EDTMP, which is currently in advanced Phase III trials, from Dow Chemicals in May. The firm reported on clinical results June 8 at the 40th Annual Meeting of Nuclear Medicine in Toronto. "In studies performed to date, pain palliation has been observed in 70%-80% of patients who received the radiotherapeutic product, with an onset of pain relief typically seen in four to seven days," Cytogen said.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth