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Kadcyla Positioned For Wide Use In Metastatic Breast Cancer

 
• By Emily Hayes

Roche is set to launch T-DM1 at the price of $9,800 a month, similar to cost of the preferred first-line regimen, which includes a combination of its own Perjeta and Herceptin. Drug was tested mostly in second-line+ mBC, but labeling allows first-line treatment in a subset of patients at high risk.

Roche’s position in the breast cancer market got even better Feb. 22 with FDA’s approval of its antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine) as a second-line option after treatment with the firm’s Herceptin and with labeling that is likely to open the door to broader application in first-line metastatic breast cancer.

Monthly Costs For Roche’s HER2 Breast Cancer Drugs

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More from Approvals

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

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Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

EU Biosimilar Filings, Opinions And Approvals

 
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

More from Product Reviews

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
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Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.