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Can Takeda's Alunbrig Take On Roche's Alecensa In First-Line ALK-Positive Lung Cancer?

 
• By Emily Hayes

Takeda's Phase III win over Pfizer's Xalkori leaves oncologists cheering, but hankering for a head-to-head study against Alecensa, which is becoming the standard of care in the US for first-line ALK+ NSCLC.

lung illustration

Takeda Pharmaceutical Co. Ltd.'s ALK inhibitor Alunbrig is now in position to challenge next-generation anaplastic lymphoma kinase (ALK) inhibitors in mutated non-small cell lung cancer (NSCLC) after pummeling Pfizer Inc.'s first-to-market Xalkori in the Phase III ALTA-1 study.

Alunbrig (brigatinib) received accelerated US FDA approval in April 2017 for use in ALK-positive NSLC after development of tolerance to...

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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.