Sign in Subscribe
Pharmaceutical industry

Oncology Drug Development: A Year of Progress and Competition in 2004

Strategic Insights

— 1 min read

The year 2004 was a significant one for the development of oncology drugs, with several new treatments gaining FDA approval and others showing promise in clinical trials. According to a study by Research and Markets, key highlights of 2004 included the fast-track designation of several drugs by the US Food and Drug Administration (FDA), including Bayer's sorafenib and Wyeth's temsirolimus for the treatment of renal cell carcinoma. Four FDA approvals were also reported, including Genentech's Avastin and ImClone's Erbitux for colorectal cancer, Eli Lilly's Alimta for mesothelioma, and Genentech's Tarceva for non-small cell lung cancer.

Key Takeaways:

  • Bayer's sorafenib and Wyeth's temsirolimus were designated fast-track status by the FDA for the treatment of renal cell carcinoma.
  • Pharmacyclics' Xcytrin (motexafin gadolinium) was fast-tracked for the treatment of brain metastases.
  • US Orphan Drug status was granted to BAY 43-9006 for renal cancer, Progen's PI-88 for melanoma, and Celgene's Revlimid for myelodysplastic syndromes.
  • Four FDA approvals were reported in 2004, including Genentech's Avastin and ImClone's Erbitux for colorectal cancer, Eli Lilly's Alimta for mesothelioma, and Genentech's Tarceva for non-small cell lung cancer.
  • AstraZeneca's Iressa and Genentech's Tarceva are competing in the treatment of non-small cell lung cancer, with Tarceva demonstrating improved survival benefits.
  • Several drugs in Phase III are being evaluated for the treatment of breast cancer, including Pfizer's Aromasin and AstraZeneca's Faslodex.
  • Roche's Xeloda is suggested as a replacement for 5-FU/LV in the adjuvant therapy of colon cancer.
  • The combination of Novartis/Schering AG's PTK787 with FOLFIRI is an option for patients with metastatic colorectal cancer.

Statistics:

  • 4 FDA approvals were reported in 2004.
  • 2 drugs (Iressa and Tarceva) are competing in the treatment of non-small cell lung cancer.
  • 7 drugs are in Phase III for the treatment of breast cancer.
  • 2 drugs (Aromasin and Faslodex) block the effects of the estrogen hormone.
  • 3 drugs (Xeloda, PTK787, and FOLFIRI) are being evaluated for the treatment of colorectal cancer.

Sources:

  • Research and Markets study (no specific date mentioned)
  • US Food and Drug Administration (FDA)
  • Genentech
  • ImClone
  • Eli Lilly
  • AstraZeneca
  • Pfizer
  • Novartis/Schering AG
  • Celgene
  • Pharmacyclics
  • Progen
  • Roche

Read more