Photo credit: Bayer Pharmaceuticals

The FDA today approved the use of the drug regorafenib (brand name Stivarga) for patients whose metastatic colorectal cancer has progressed despite all currently approved treatment regimens.

This is the second new drug approved by the FDA recently after a drought of 5 years in approving new treatments for metastatic colorectal cancer (mCRC). Regorafenib was placed into the  FDA’s “fast-track” approval process after the international, multicenter Phase III CORRECT trial  showed improved survival (from 5 to 6.4 months) in all mCRC patients, including those having both non-mutated and mutated KRAS types. Read the rest of this entry »

Ziv-Aflibercept Approved as 2^nd line treatment for metastatic CRC  

For the first time in more than five years, the FDA has approved a new drug for certain patients who have metastatic colorectal cancer.

The FDA has approved ZALTRAP® (ziv-aflibercept) to be used with FOLFIRI as a “second-line” treatment for patients with stage IV colorectal cancer whose cancer got worse despite an initial oxaliplatin-based treatment (e.g. FOLFOX).  Read the rest of this entry »

The FDA has approved Erbitux™ (cetuximab) in combination with FOLFIRI for first-line treatment of patients with metastatic colorectal cancer whose tumors have a wild-type (WT) KRAS gene.  Erbitux was first approved in 2004 for patients whose cancer was not responding to available treatments.

FDA’s action was prompted by results from a look back at patient outcomes and KRAS status from three trials:

• CRYSTAL:  phase 3, 1217 patients newly diagnosed with metastatic CRC, comparing FOLFIRI vs FOLFIRI + Erbitux
• OPUS: phase 2, 337 patients newly diagnosed with metastatic CRC, comparing FOLFOX vs FOLFOX + Erbitux
• CA225025: phase 3, 572 patients with metastatic CRC that stopped responding to available treatments, comparing Best Supportive Care (BSC) to BSC + Erbitux

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Chris Adams at Fight Colorectal Cancer's 2012 Call-on Congress

Written by: Christopher P. Adams, Ph.D.*

Chris Adams, one of Fight Colorectal Cancer’s research advocates, shares his thoughts about the results of a large breast cancer trial presented at the 2012 ASCO in Chicago, and aspects of the regulatory process. Thank YOU Chris!

On Sunday June 3 2012, at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Dr Kimberly Blackwell from the Duke Cancer Institute, got on stage in front of over 10,000 doctors, researchers and worldwide media representatives to present initial results from the EMILIA trial.** The trial looked at the safety and effectiveness of a novel drug for a particular type of breast cancer. Despite its obvious applicability to breast cancer, the colorectal cancer community and the larger cancer community can learn a number of important things from EMILIA.

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The counterfeit drug trade has reached global proportions, and solving the problem needs a global approach.

So says an editorial in this week’s The Lancet.

While the Avastin announcement last week raised lots of concern and media attention, the issue of counterfeit drugs isn’t new. In 2009, the European Union seized 34 million fake pills in just two months, including antibiotics, cancer drugs, and sildenafil (Viagra). Counterfeit medicines are a problem for both low and high income countries and can seriously hurt patients.

In January the FDA warned healthcare providers not to buy injectable cancer medications from “direct-to-clinic” promotions or non-verified sources. Such drugs, says the FDA, put patients at risk. Read the rest of this entry »