Pfizer (NYSE:PFE) said it is removing its leukemia drug Mylotarg from the market after a study found higher death rates and no benefit for patients using the drug. The approval of Mylotarg in the United States was granted under FDA's accelerated approval regulations based on overall response rate in three non-comparative studies and required submission of additional data to confirm clinical benefit. The required post-approval study combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated acute myeloid leukemia.
Pfizer said it has suspended development of tanezumab, a monoclonal antibody for the treatment of osteoarthritis. The decision followed a request by the U.S. Food and Drug Administration and comes after reports of a small number of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab, the company said. The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA has asked Pfizer to present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoarthritis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is working with the agency to determine the appropriate course of action.
Exelixis (NASDAQ:EXEL) said it had regained rights to its experimental cancer drug XL184 after Bristol-Myers Squibb (NYSE:BMY) had ended its development agreement over the so-called MET inhibitor. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials. Given the recent progress of BMS' wholly-owned oncology pipeline and positive data generated by XL184, Exelixis and BMS were not able to agree on the scope, breadth and pace of the ongoing clinical development of XL184. BMS will make a payment to Exelixis of $17 million in connection with the return of XL184. “We certainly understand BMS' need to make pipeline and prioritization decisions, but from Exelixis' perspective, XL184 is our most advanced compound, the data are encouraging, and we need to rapidly develop the compound in indications justified by the data,” says George Scangos, CEO of Exelixis.