Stivarga (regorafenib), a multi-kinase inhibitor, gained FDA approval for treating metastatic colorectal cancer that has progressed despite prior treatment. It's administered in tablet form, taken orally.
Developed by Bayer Health Care, Stivarga remains under the company's ownership. Bayer entered an agreement with Onyx Pharmaceuticals Inc., entitling Onyx to royalties from Stivarga's future global oncology sales. The drug will be jointly promoted in the USA by Onyx and Bayer.
Stivarga blocks a several enzymes which are involved in encouraging cancer growth. The medication underwent FDA assessment through a priority review program, streamlining approval within six months. Priority review programs are assigned to drugs or treatments for which there are no existing adequate therapies, or to compounds that offer major treatment advances.
The medication received approval a month ahead of its prescription user fee goal date (October 27th, 2012), aligning with the FDA's review timeline.
Dr. Richard Pazdur, Director of the FDA's Office of Hematology and Oncology Products, remarked, that "Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients' lives and is the second drug approved for patients with colorectal cancer in the past two months."
Dr. Heinz-Josef Lenz, CORRECT investigator and USC Norris Comprehensive Cancer Center's associate director for clinical research and co-leader of the Gastrointestinal Cancers Program, highlighted Stivarga's significance in offering options for metastatic colorectal cancer patients without further treatment possibilities. The drug exhibited efficacy in prolonging survival and slowing cancer progression after treatment with currently available therapies.
Colorectal cancer stands as the USA's third leading cause of cancer-related deaths, according to the CDC, ranking as the third most prevalent cancer among adults in the country.
This year, the NIH estimates 51,690 deaths and 143,460 diagnoses of colorectal cancer in the USA.
The FDA evaluated a clinical trial involving 760 previously treated colorectal cancer patients, randomly dividing them into Stivarga and placebo groups. Both received supportive care for managing side effects and cancer symptoms.
Results revealed:
- Stivarga group: Median survival of 6.4 months.
- Placebo group: Median survival of 5 months.
- Stivarga group: Median progression-free survival of 2 months.
- Placebo group: Median progression-free survival of 1.7 months.
The approved drug carries a Boxed Warning, advising doctors and patients on the risk of severe and potentially fatal liver toxicity which was observed in the Stivarga trials.
Common side effects reported in the clinical trial include diarrhea, dysphonia, fatigue, high blood pressure, infections, mouth sores, palmar-plantar erythrodysesthesia (hand-foot syndrome), decreased appetite, weakness, and weight loss.
Additionally, Zaltrap (ziv-aflibercept) received approval in August 2012 for use with the FOLFIRI (folinic acid fluorouracil and irinotecan) chemotherapy regimen in adults with metastatic colorectal cancer.
Colorectal cancer, or bowel cancer, refers to any tumor in the colon or the rectum. It ranks as the second most prevalent cancer globally after lung cancer, according to the WHO.
Risk factors associated with colorectal cancer include age, diet high in animal protein and saturated fats, low dietary fiber, excessive alcohol consumption, family history, obesity, smoking, physical inactivity, ulcerative colitis, presence of polyps in the colon or rectum, Crohn's disease, or irritable bowel syndrome (IBS).