Pfizer's Mylotarg Finally Gets CHMP Nod But No New Indication For Sutent

The EMA is finally set to approve Pfizer's targeted anticancer Mylotarg for use in acute myeloid leukemia. The company also received opinions for Bosulif and Sutent. 

Crocus
New Life for Mylotarg • Source: Shutterstock

The EU's CHMP has granted a positive opinion to Pfizer Inc.'s targeted anticancer Mylotarg (gemtuzumab ozogamicin) for use in acute myeloid leukemia (AML), setting the stage for an arrival in the EU market more than a decade after its first attempt. The decision was one of three taken by the committee on Pfizer drugs at its February meeting last week.

Mylotarg is set for approval for the treatment of AML in patients aged 15 years and above, with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL), in combination with daunorubicin and

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

More from New Products

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Biopharma Deals ROI Has Fallen And Market Instability Could Make It Worse

 

Rising biotech valuations mean return on investment on some deals is non-existent for big pharma, though certain strategies will improve chances of success, a new analysis has found.

Pipeline Watch: Six Approvals And Thirteen 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.

More from Scrip

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Executives On The Move: Pathos Procures CEO From AstraZeneca, New CEO For TME Pharma, And More

Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.