Thursday, Aug 14, 2014
FDA Approves Genentech’s Avastin Plus Chemotherapy for Treatment of Advanced Cervical Cancer
Avastin is the First Biologic Medicine Approved in Combination with Chemotherapy to Help Women with This Type of Cancer Live Longer Than with Chemotherapy Alone
South San Francisco, Calif. -- August 14, 2014 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Avastin® (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
“With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.”
With this approval in advanced cervical cancer, Avastin is approved in the United States to treat five distinct tumor types. The approval in advanced cervical cancer was based on the GOG-0240 study.
Genentech Access Solutions offers patient assistance for people taking Avastin who meet certain eligibility criteria. More information is available by calling (866) 4ACCESS/(866) 422-2377 or visiting http://www.Genentech-Access.com.
About the GOG-0240 Study
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study conducted by the Gynecologic Oncology Group (GOG), which assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer. Study data from 452 women showed:
- The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 16.8 months vs. 12.9 months; Hazard Ratio [HR]=0.74, p=0.0132).
- The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone (45 percent [95% CI: 39%-52%] vs. 34 percent [95% CI: 28%-40%]), respectively.
- Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (29 percent vs. 6 percent), but no patients discontinued Avastin because of hypertension. Grade 3 or higher thrombosis (blood clots) were significantly increased with the Avastin-containing regimens (8.3 percent vs. 2.7 percent). Gastrointestinal-vaginal fistulas (abnormal passage from one part of the body to another) occurred in 8.2 percent of patients receiving Avastin-containing regimens compared to 0.9 percent with chemotherapy alone, all of whom had a history of prior pelvic radiation. Patients who develop these fistulas may require additional surgery. Additionally, 1.8 percent of Avastin‑treated patients and 1.4 percent of control patients were reported to have had non-gastrointestinal fistulas in the vaginal, vesical or female genital tract.
- There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.
About Cervical Cancer
It is estimated that more than 12,000 new cases of cervical cancer will be diagnosed in the United States in 2014 and about 4,000 women will die from the disease. There is a dramatic difference in survival rates between early and advanced cervical cancer. At least nine out of 10 women will live for five years following diagnosis of early stage disease but the survival rate drops to below one in six women when the disease has spread to other parts of the body (metastasis).
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 300 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).
Avastin U.S. Indications:
- Avastin is approved for the first or second line treatment of patients with metastatic colorectal cancer in combination with intravenous 5 fluorouracil–based chemotherapy.
- Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is approved for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first line Avastin-containing regimen.
- Avastin is not approved for adjuvant treatment of colon cancer.
- Avastin, in combination with carboplatin and paclitaxel chemotherapy, is approved for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer.
- Avastin is approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
- Avastin is approved in combination with paclitaxel and cisplatin or paclitaxel and topotecan for treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
BOXED WARNINGS and Additional Important Safety Information
People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:
Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (3.2 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.
Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin.
Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.
Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 0.4 percent to 6.9 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.
In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage in the body (GI and non-GI fistula formation) was seen in up to 2% of people. In a study of patients with cervical cancer, formation of an abnormal passage between the vagina and GI tract was seen in 8.2% of people. Severe to life-threatening stroke or heart problems were seen in 2.6 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening blood clots (VTE), up to 10.6%, severe to life threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (Posterior Reversible Encephalopathy Syndrome) which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people. Avastin can cause fertility issues for women. Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children.
Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.
Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.
Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother.
In the cervical cancer trial, the most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus chemotherapy compared to those receiving chemotherapy alone were abdominal pain (11.9% vs. 9.9%), diarrhea (5.5% vs. 2.7%), abnormal opening at or near the anus (3.7% vs. 0%), pain at the anus or the rectum (2.8% vs. 0%), urinary tract infections (8.3% vs. 6.3%), skin infection (3.2% vs. 0.5%), tiredness (14.2% vs. 9.9%), high blood pressure (11.5% vs 0.5%), blood clot formation (8.3% vs 2.7%), low potassium (7.3% vs. 4.5%), abnormally low sodium that could lead to seizure or coma (3.7% vs. 1.4%), dehydration (4.1% vs. 0.5%), lower than normal white blood cell count [neutropenia (7.8% vs. 4.1%), lymphopenia (6.0% vs. 3.2%)], back pain (5.5% vs. 3.2%), and pain in the lower part of your abdomen (5.5% vs. 1.4%).
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For full Prescribing Information and Boxed WARNINGS on Avastin, please visit http://www.avastin.com.
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.