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

Multiple Factors Driving Japan’s Pioneering Angiosarcoma Pipeline

 
• By Lisa Takagi

Japan has emerged as a global leader in the development of new drugs for the rare cancer angiosarcoma, reflecting its rapidly ageing population and the limitations of current therapies.

Prasad’s Exit From CBER Could Bode Well For Genetic Medicines

 
• By Jessica Merrill

Pharma companies like Sarepta, Replimune and Capricor made gains on Wall Street after news broke that the FDA Center for Biologics Evaluation and Research director Vinay Prasad is leaving.

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

Lilly’s Jaypirca Threatens Imbruvica’s CLL Position After Phase III Results

 
• By Alaric DeArment

The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.

More from Therapy Areas

Biogen Edges Closer To Growth On Strong Q2

 
• By Jessica Merrill

Sales of Leqembi, Zurzuvae and Skyclarys contributed to Biogen’s sales and earnings guidance raise, positioning the company closer to potential growth.

Amvuttra Makes Strong ATTR-CM Showing As Alnylam Prepares For Global Launches

 
• By Alaric DeArment

In an interview, chief commercial officer Tolga Tanguler gave some ideas of what to expect as the company prepares to launch the drug for ATTR-CM in Europe.

Argenx Powers Ahead With Vyvgart’s Prefilled Syringe Launch

 
• By Andrew McConaghie

The Netherlands-headquartered company is enjoying huge success with Vyvgart in two autoimmune conditions, with a new prefilled syringe version reaching more patient groups.