Cometriq Thyroid Approval May Open Door For Use In Prostate Cancer

As cabozantinib wins FDA approval for the rare medullary thyroid cancer, Exelixis stresses its broader development program in other tumor types, notably prostate cancer. The company is likely to submit prostate cancer data to compendia, which if successful could enable reimbursement for the off-label use.

Exelixis Inc.is expected to submit positive trial data for Cometriq (cabozantinib) in prostate cancer to the national drug compendia, a move – following the drug’s approval in rare medullary thyroid cancer – that could enable use and reimbursement in a much larger indication prior to formal clearance.

Cometriq is an oral inhibitor of several kinases including MET, RET and VEGFR2. On Nov. 29, the drug cleared FDA...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Market Access

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By 

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

Leqembi Facing 15% Price Cut In Japan

 
• By 

Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

 
• By 

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

More from Pink Sheet

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.