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Ibrutinib Results Suggest Potential To Shake Up CLL Market

 
• By Emily Hayes

Momentum builds for Pharmacyclics/J&J’s ibrutinib with release of new data at the American Society of Hematology meeting, suggesting the drug has a shot at accelerated approval in sub-populations with high unmet need and potential in a range of B-cell cancers. Profiles of competitors from Gilead and Infinity/Takeda also came into greater focus at ASH.

The presentation of results for Pharmacyclics Inc./Johnson & Johnson’s oral BTK inhibitor ibrutinib at the American Society of Hematology meeting spurred talk of a potential for a change in the standard of care for chronic lymphocytic leukemia, with potential to shift treatment away from a chemotherapy-based, all-intravenous approach toward targeted oral therapy.

Ibrutinib (PCI-32765) inhibits Bruton’s tyrosine kinase, a target at the heart of B-cell receptor signaling. Janssen Biotech licensed co-development rights...

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CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.