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The approval makes the third-generation tyrosine kinase inhibitor (TKI) the first targeted treatment approved for upfront use in adults with Ph+ ALL, Takeda said in a press release.
Ponatinib was previously approved as monotherapy for Ph+ ALL when no other kinase inhibitors are indicated or for T315I-positive Ph+ ALL, as well as for chronic myeloid leukemia.
Approval for the new indication was based on the PhALLCON trial. In the trial, 245 patients were randomized 2:1 to either ponatinib 30 mg once daily or the first-generation TKI imatinib (Gleevec, Novartis) 600 mg once daily on a chemotherapy background consisting of three cycles of vincristine/dexamethasone induction, six cycles methotrexate/cytarabine consolidation, and 11 cycles of vincristine/prednisone maintenance.
At the end of induction, 12% of patients in the imatinib arm vs 30% in the ponatinib group were in complete remission with no minimal residual disease. Event-free survival data are not yet mature.
At the 2023 American Society of Clinical Oncology annual meeting, an investigator on the trial said that ponatinib plus low-intensity chemotherapy has the potential to become the new standard of care for upfront Ph+ All. However, continued approval for the new indication may depend on trials confirming clinical benefit, Takeda said.
Ponatinib carries a boxed warning of arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity.
The most common adverse reactions reported in the PhALLCON trial were hepatic dysfunction, arthralgia, rash, headache, pyrexia, abdominal pain, constipation, fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.
The recommended ponatinib dose is 30 mg orally once daily until the end of induction, dropping down to 15 mg once daily in patients who go into remission with no minimal residual disease after induction, for up to 20 cycles or until loss of response or unacceptable toxicity.
Thirty tablets of 30 mg or 15 mg cost $21,944.54, according to Drugs.com.
A version of this article appeared on Medscape.com.
The approval makes the third-generation tyrosine kinase inhibitor (TKI) the first targeted treatment approved for upfront use in adults with Ph+ ALL, Takeda said in a press release.
Ponatinib was previously approved as monotherapy for Ph+ ALL when no other kinase inhibitors are indicated or for T315I-positive Ph+ ALL, as well as for chronic myeloid leukemia.
Approval for the new indication was based on the PhALLCON trial. In the trial, 245 patients were randomized 2:1 to either ponatinib 30 mg once daily or the first-generation TKI imatinib (Gleevec, Novartis) 600 mg once daily on a chemotherapy background consisting of three cycles of vincristine/dexamethasone induction, six cycles methotrexate/cytarabine consolidation, and 11 cycles of vincristine/prednisone maintenance.
At the end of induction, 12% of patients in the imatinib arm vs 30% in the ponatinib group were in complete remission with no minimal residual disease. Event-free survival data are not yet mature.
At the 2023 American Society of Clinical Oncology annual meeting, an investigator on the trial said that ponatinib plus low-intensity chemotherapy has the potential to become the new standard of care for upfront Ph+ All. However, continued approval for the new indication may depend on trials confirming clinical benefit, Takeda said.
Ponatinib carries a boxed warning of arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity.
The most common adverse reactions reported in the PhALLCON trial were hepatic dysfunction, arthralgia, rash, headache, pyrexia, abdominal pain, constipation, fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.
The recommended ponatinib dose is 30 mg orally once daily until the end of induction, dropping down to 15 mg once daily in patients who go into remission with no minimal residual disease after induction, for up to 20 cycles or until loss of response or unacceptable toxicity.
Thirty tablets of 30 mg or 15 mg cost $21,944.54, according to Drugs.com.
A version of this article appeared on Medscape.com.
The approval makes the third-generation tyrosine kinase inhibitor (TKI) the first targeted treatment approved for upfront use in adults with Ph+ ALL, Takeda said in a press release.
Ponatinib was previously approved as monotherapy for Ph+ ALL when no other kinase inhibitors are indicated or for T315I-positive Ph+ ALL, as well as for chronic myeloid leukemia.
Approval for the new indication was based on the PhALLCON trial. In the trial, 245 patients were randomized 2:1 to either ponatinib 30 mg once daily or the first-generation TKI imatinib (Gleevec, Novartis) 600 mg once daily on a chemotherapy background consisting of three cycles of vincristine/dexamethasone induction, six cycles methotrexate/cytarabine consolidation, and 11 cycles of vincristine/prednisone maintenance.
At the end of induction, 12% of patients in the imatinib arm vs 30% in the ponatinib group were in complete remission with no minimal residual disease. Event-free survival data are not yet mature.
At the 2023 American Society of Clinical Oncology annual meeting, an investigator on the trial said that ponatinib plus low-intensity chemotherapy has the potential to become the new standard of care for upfront Ph+ All. However, continued approval for the new indication may depend on trials confirming clinical benefit, Takeda said.
Ponatinib carries a boxed warning of arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity.
The most common adverse reactions reported in the PhALLCON trial were hepatic dysfunction, arthralgia, rash, headache, pyrexia, abdominal pain, constipation, fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.
The recommended ponatinib dose is 30 mg orally once daily until the end of induction, dropping down to 15 mg once daily in patients who go into remission with no minimal residual disease after induction, for up to 20 cycles or until loss of response or unacceptable toxicity.
Thirty tablets of 30 mg or 15 mg cost $21,944.54, according to Drugs.com.
A version of this article appeared on Medscape.com.