Older Drug Gets New Indication for Use in Aggressive Cancer

A drug that the FDA first approved more than a decade ago was recently approved for the first-line treatment of an aggressive blood cancer. One clinical trial showed that people on the agent experienced complete remission more than twice as often as those on a comparator therapy.

On March 19, the FDA gave accelerated approval to Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.

The approval makes the tyrosine kinase inhibitor (TKI) the first and only FDA-approved targeted treatment for the indication.

The recommended dose of the newest use of the tablet is 30 mg once daily, with a reduction to 15 mg once daily at the end of the induction phase, which is three cycles of treatment, and after achieving minimal residual disease (MRD)-negative complete remission. Drugs.com lists the price of 30 tablets of all four strengths — 10 mg, 15 mg, 30 mg and 45 mg — as more than $21,944.

The agency initially approved the drug on Dec. 14, 2012. Among its other indications is the treatment of Ph+ ALL that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.

The newest indication was granted accelerated approval based on MRD-negative complete remission at the end of the induction phase.

Ph+ ALL has an incidence of 2% to 5% in children but represents about 20% to 25% of adults with ALL, making it the most common genetic subgroup among that latter patient population. Incidence of Ph+ ALL increases with age, and it makes up more than half of the ALL cases in people older than 50.

“Ph+ ALL is an extremely aggressive cancer and patients with this disease suffer from poor outcomes. There has long been a need for a potent TKI that can suppress mutation development and elicit deep responses in the frontline,” said Elias Jabbour, M.D., a professor of medicine in the department of leukemia at the University of Texas MD Anderson Cancer Center and lead investigator of the Phase III PhALLCON trial. “Ponatinib may help address these factors and impact long-term outcomes.”

In the PhALLCON clinical trial, people received either Iclusig — a third-generation TKI — or imatinib — a first-generation TKI that was initially approved May 10, 2001, as Novartis Pharmaceutics Corp.’s Gleevec — plus reduced-intensity chemotherapy. Those in the Iclusig arm had a 30% MRD-negative complete remission rate at the end of induction compared with a 12% rate in the imatinib arm.

For the Managed Care Oncology Index: Q2 2023, from May 24, 2023, to June 27, 2023, Zitter Insights polled 34 commercial payers covering 116.1 million lives, 30 Medicare payers covering 43.3 million lives, 50 oncologists and 50 practice managers about their management of and prescribing for ALL. Payers with 40% of commercial lives said they rate managing brand treatments for the condition a high or very high priority, while those with 68% of Medicare lives said the same (see chart). Payers with 73% of covered commercial lives and 56% of Medicare members said they are somewhat aggressive in their management of branded agents, meaning that they cover all agents, but some may be preferred over others through the use of tiering, step edits and/or prior authorization.

Fourteen percent of all payers expressed high satisfaction with current ALL treatments compared with 40% of oncologists. Payers representing 77% of commercial lives and 75% of Medicare lives said there is a high or very high unmet need in treating ALL.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.

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