1. Scrip
  2. >>Therapy Areas
  3. >>Anticancer

Puma's Neratinib Gets CHMP Turnaround But Slow EU Uptake Expected

 
• By Jo Shorthouse

Puma Biotech has proven to be the cat with nine lives after its HER2+ breast cancer treatment neratinib received a u-turn from CHMP, granting it a positive trend vote. But even if final marketing approval is granted this year, European prospects don’t necessarily follow.

U turn
CHMP has reversed its negative trend vote for neratinib

In an unusual move, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has changed its mind on the merits of a product that it had originally said should not be approved for sale in the EU.

The beneficiary is Puma Biotechnology Inc. and the product is neratinib, the company's kinase inhibitor for the extended adjuvant...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Anticancer

Kymera Inks CDK2 Deal With Gilead

 
• By Alaric DeArment

Deal Snapshot: The biotech will receive up to $750m from Gilead for molecular glue degraders against CDK2.

Nuvalent Believes Safety Profile Can Help Zidesamtinib Be ROS-1 Lung Cancer Leader

 
• By Andrew McConaghie

Zidesamtinib would be the fifth ROS-1 targeting therapy on the market, but Nuvalent believes its safety and efficacy profile will make it the best in class.

Exelixis Positions Zanzalintinib For Post-Cabozantinib LOE Future

 
• By Alaric DeArment

The company announced positive Phase III data in previously treated colorectal cancer for zanzalintinib and it could see sales of more than $1bn in that indication.

J&J’s Trispecific Antibody For Myeloma Offers Improved Safety, Potency Over Bispecifics

 
• By Alaric DeArment

The drugmaker presented data from its Phase I study of JNJ-79635322 at ASCO and EHA showing a 100% response rate in BCMA- and GPRC5D-naïve patients.

More from Therapy Areas

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By Joseph Haas

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

Industry’s Vaccines Pipeline In A Changing Regulatory Landscape

 
• By Jessica Merrill

More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.

Sanofi Links Up Again With Formation To Take Gusacitinib Down New Path

 
• By Kevin Grogan

Deal Snapshot: The Paris-headquartered company has licensed gusacitinib, which was in development for chronic hand eczema, but Sanofi will pursue a new indication for the dual JAK/SYK inhibitor.