Roche's T-DM1 Early Filing Strategy Backfires as FDA Refuses to File BLA

The Pink Sheet Daily. 2010 Aug 27, J Merrill

It hasn't been a swell summer for Roche, and now a bit of near-term pipeline news that could have put the company on a more positive trajectory has fallen flat. FDA refused to file Roche's BLA for breast cancer agent trastuzumab-DM1 (T-DM1), a conjugated version of Herceptin , for accelerated approval, the company announced Aug. 27. Roche has already faced two significant pipeline setbacks this summer, a disappointing advisory committee review for Avastin (bevacizumab) in breast cancer and safety...

NOT A MEMBER?

Registration is FREE

  • Up-to-date oncology news
  • Journal article summaries
  • Commentaries and interviews
  • Drug and interactions database
  • Chemotherapy regimens
  • Daily e-newsletters

 

Meet Our Experts

Meet our Advisory and Editorial Boards comprised of physician editors and world-renowned experts.

Editors' Choice

Long-Term Posttransplant Bortezomib Boosts Outcome in Myeloma With del(17p13)

Cancer Type

  • Bladder
  • Bone
  • Breast
  • Breast (ER-Positive)
  • CNS/Brain
  • Colon and Rectum
  • Endocrine System
  • Esophagus
  • GYN (Non-Ovary)
  • GYN (Ovary)
  • Head and Neck
  • Hodgkin's Lymphoma
  • Kidney (Renal Cell)
  • Leukemia
  • Liver and Bile Duct
  • Lung
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myeloproliferative Diseases
  • Non-Hodgkin's Lymphoma
  • Pancreas
  • Pediatric Cancers
  • Prostate
  • Rare Cancers
  • Skin
  • Soft-Tissue Sarcoma
  • Stomach
  • Testicle
  • Forgot your password?
    Not a member? Free registration