FDA Oncology Updates

We’re keeping an eye on the FDA. The recent weather resulted in the postponement of some very important ODAC meetings, which have yet to be rescheduled. In addition, some companies have been working with the FDA to design trials for investigational products. The following 10 items outline recent actions by the FDA involving drugs or devices designed to treat patients with cancer.

• In January, the FDA announced a Class I recall of more than 2 million Exel/Exelint Huber needles and infusion sets made between January 2007 and August 2009. The needles are used to access implanted ports in chronically ill patients and may cut the silicone cores. As a result, slivers may enter the bloodstream, causing embolism or other health problems. The slivers could also lodge in the needle, obstructing delivery of medication.

• The FDA has approved an expanded indication for Tykerb (lapatinib) that allows it to be administered with Femara (letrozole) to treat hormone-positive and HER-2 positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

• The FDA has granted orphan drug designation to Graspa, a new enzyme formulation of L-asparaginase that is used to treat acute lymphoblastic leukemia. Erytech Pharma says it is in talks with key opinion leaders in the United States to initiate new clinical trials with Graspa.

• FDA staff reviewing the effectiveness of pixantrone (Pixuvri) for non-Hodgkin's lymphoma expressed concern that Cell Therapeutics had not provided enough evidence of the drug's effectiveness in light of its "substantial hematologic and cardiac toxicity." A scheduled ODAC meeting has been postponed because of inclement weather.

• The FDA staff also questioned the effectiveness of Omapro by ChemGenex in patients with chronic myeloid leukemia who have the T315I mutation, which conveys resistance to current tyrosine kinase inhibitors. The study failed to meet accrual goals. The FDA also noted no approved test exists for the T315I mutation. The agency plans to seek advice from an ODAC advisory panel.

• Onyx Pharmaceuticals has reached an agreement with the FDA on the design of a phase III trial for carfilzomib in relapsed multiple myeloma. Onyx expects to start accruing patients in the first half of 2010 (see Oncology & Biotech News, January issue).

• Cellceutix Corporation announced that a pre-Investigational New Drug exemption meeting with the FDA was successful, and animal studies for Keyetrin, which is being investigated for drug-resistant cancers, are underway to determine the safety of the drug’s pharmacologic profile, in particular regarding the cardiovascular and central nervous systems.

• The FDA had been debating what to do about erythropoiesis-stimulating agents used to treat anemia in cancer patients after studies showed the drugs contributed to the death of some patients. It has now developed a risk-management plan with Amgen and Johnson & Johnson that requires the companies to do more to publicize the safety risks of these drugs. In addition, Amgen and Johnson & Johnson will be required to register each oncologist who prescribes Amgen’s Aranesp or Epogen and Johnson & Johnson’s Procrit, documenting that they have discussed the risks of these drugs before prescribing them.

• Delcath Systems, which makes a drug delivery system for liver metastases, said the FDA has granted permission for an Expanded Use-Intermediate Size Population protocol for the hepatic arterial infusion of melphalan with venous infiltration using its proprietary Delcath PHP System. The Expanded Use covers patients with ocular and cutaneous melanoma metastatic to the liver.

• The FDA has announced that it is going to take a proactive approach to regulating radiation associated with CT scans, nuclear medicine studies, and fluoroscopies. This follows reports of patients receiving excessive amounts of radiations and a study that showed radiation from these procedures can increase an individual’s risk of developing cancer. The FDA is holding a public meeting on March 30-31 to solicit input. Some of the measures being considered are displays that indicate radiation dose, an alert system when the radiation exceeds an optimal dose, and better training for technicians using the devices.