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Takeda’s Iclusig Looks Set To Become SOC In First-Line Ph+ Acute Lymphoblastic Leukemia

 
• By Alaric DeArment

The drug beat out imatinib on efficacy while not drawing any increased concerns about safety, and an investigator told Scrip it should replace imatinib as first-line standard of care in the rare ALL subtype.

Takeda unveiled data from the Phase III PhALLCON trial of Iclusig in an ASCO monthly plenary session • Source: Shutterstock

After more than a decade on the market, Takeda Pharmaceutical Co. Ltd.’s Iclusig (ponatinib) looks set to become standard of care in the first-line treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults, based on data from a Phase III trial comparing it against a targeted therapy used off-label in that indication, imatinib (Novartis AG’s Gleevec and generics).

Takeda presented data from the Phase III PhALLCON trial on 15 February at the American Society of Clinical Oncology’s monthly...

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Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By Aakash Babu

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 
• By Alaric DeArment

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By Mandy Jackson

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.

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IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By Mandy Jackson

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.