ESAs spared ax at ODAC meeting

Erythropoietin-stimulating agents were spared the ax when FDA’s Oncologic Drugs Advisory Committee (ODAC) decided by a vote of 13-to-1 that ESAs should remain available for use in cancer patients with chemotherapy-induced anemia. ODAC did, however, recommend further restrictions on ESA use in these patients (see Table on page 8), some of which created concern and confusion among oncology leaders at the meeting.

 Since the 2007 ODAC meeting, new data from two studies became available, prompting FDA to call yet another ODAC meeting on this issue. The PREPARE study, a European neoadjuvant breast cancer trial, showed a slight numeric decrease in survivorship in the ESA arm, compared with the placebo arm. GOG-191, a gynecological group study of cervical cancer patients, also showed an increase in numeric mortality in the ESA arm. However, as with previous data showing problems with ESAs, both studies targeted hemoglobin levels higher than the currently approved product label.

“To be perfectly honest, there really weren’t any new data at the ODAC meeting. The arms of both studies were not statistically significantly different; there was just a trend,” said Samuel Silver, MD, PhD, of the University of Michigan and chair of ASH’s subcommittee on reimbursement.

Dr. Silver told Oncology News International that he felt there was no new information presented at the meeting that warranted changing the indications or labeling of ESAs. He was also concerned about confusion coming out of some of the rulings.

Who defines ‘potentially curative’?

“The committee voted overwhelmingly to modify ESA indications for potentially curative treatment. So that begs the questions about exactly what is curative treatment?” he said. Who determines whether you’re treating for cure? How will the language be written to make that clear? he asked.

“In lymphoma patients you could have stage IV, widely disseminated, intermediate-grade lymphoma treated curatively or as you could have a low-grade lymphoma with a lesser stage that cannot be treated curatively,” he said.

ASCO executive vice president and ONI board member Joseph S. Bailes, MD, said that ASH and ASCO are collaborating on an education initiative about ESA usage.

 “This is an important initiative simply because of how much confusion can be generated in the community setting by ODAC’s action,” Dr. Bailes told ONI.

 He stressed that it is important for community practitioners to keep abreast of the changes in ESA reporting.

 “For example, you must report the most recent hemoglobin or hematocrit levels on any claim for a Medicare patient receiving ESA administrations or Part B anti-anemia drugs other than ESAs that are not self-administered,” Dr. Bailes commented.