FDA approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program.”
Avastin interferes with the blood vessels that fuel the development of cancerous cells. Avastin is also approved in the U.S. to treat cancers of the colon, kidney, and lung. The approval in advanced cervical cancer was based on the GOG-0240 study, which enrolled 452 participants with persistent, recurrent, or late-stage disease.
Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.
GOG-0240 is an independent, NCI-sponsored study of the Gynecologic Oncology Group. Avastin is marketed by Genentech, a member of the Roche Group.
FDA approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
Using a stool sample, Cologuard detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy.
The Centers for Disease Control and Prevention estimate that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided.
“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test.”
This approval does not change current practice guidelines for colorectal cancer screening. Stool DNA testing is not currently recommended as a method to screen for colorectal cancer by the U.S. Preventive Services Task Force. Among other guidelines, the USPSTF recommends adults age 50 to 75, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy or colonoscopy.
The safety and effectiveness of Cologuard was established in a clinical trial that screened 10,023 subjects. The trial compared the performance of Cologuard to the fecal immunochemical test, a non-invasive screening test that detects blood in the stool.
Cologuard accurately detected cancers and advanced adenomas more often than FIT, detecting 92 percent of colorectal cancers and 42 percent of advanced adenomas in the study population, while FIT screening detected 74 percent of cancers and 24 percent of advanced adenomas.
Cologuard was less accurate than FIT at correctly identifying subjects negative for colorectal cancer or advanced adenomas. Cologuard correctly gave a negative screening result for 87 percent of the study subjects, while FIT provided accurate negative screening results for 95 percent of the study population, according to Cologuard’s sponsor, Exact Sciences.
The Centers for Medicare & Medicaid Services issued a proposed national coverage determination for Cologuard. Cologuard is the first product reviewed through a joint FDA-CMS pilot program known as parallel review where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage.
This voluntary pilot program is open to certain premarket approval applications for devices with new technologies and to medical devices that fall within the scope of a Part A or Part B Medicare benefit category and have not been subject to a national coverage determination.
“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as six months from the time from study initiation to coverage,” said Nancy Stade, CDRH’s deputy director for policy. “The pilot program is ongoing, but we will apply what we have learned to improve the efficiency of the medical device approval pathway for devices that address an important public health need.”
“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS. “This parallel review represents unprecedented collaboration between the two agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”
CMS proposes to cover the Cologuard test once every three years for Medicare beneficiaries who meet all of the following criteria: age 50 to 85 years; asymptomatic, including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test; and an average risk of developing colorectal cancer, including no personal history of adenomatous polyps, of colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis.
Health Canada approved Abraxane for Injectable Suspension for first-line treatment of adult patients with metastatic pancreatic cancer, representing the first approved treatment for this disease in nearly two decades.
Approval of Abraxane (paclitaxel powder for injectable suspension; nanoparticle, albumin-bound paclitaxel) was based on the results of MPACT, an open-label, phase III, randomized, international study which was published in the New England Journal of Medicine in October 2013.
The study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer from 11 countries, including Canada, and showed a statistically significant improvement in median overall survival with Abraxane plus gemcitabine compared to gemcitabine alone: 8.5 vs. 6.7 months, respectively (HR 0.72, P<0.0001); a 28 percent overall reduction in risk of death.
“It’s been quite some time since we’ve seen any type of treatment advance for pancreatic cancer making this news so important for patients.” said Laurie Ellies, co-founder and acting executive director of Pancreatic Cancer Canada. “Over the past decade, there has been a significant improvement in cancer survival rates. Sadly, the same cannot be said about pancreatic cancer.
“This year alone, we can expect an estimated 4,700 Canadians will be diagnosed with this disease.”
Abraxane is formulated with albumin, a human protein, and is free of solvents. Abraxane in combination with gemcitabine for the treatment of metastatic pancreatic cancer is approved in the U.S. and 30 other countries.
The European Medicines Agency approved Eisai’s request for accelerated assessment of lenvatinib for the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer.
Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors, in addition to other proangiogenic and oncogenic pathway-related RTKs, including fibroblast growth factor receptors, the platelet-derived growth factor receptor PDGFRalpha, KIT, and RET.
Lenvatinib received orphan drug designation for the treatment of follicular and papillary thyroid cancer from the European Commission in April 2013.
The EU marketing authorization application will be based on the results of the Phase III SELECT trial of lenvatinib that demonstrated extended progression free survival compared to placebo (HR=0.21, [99% CI, 0.14-0.31]; p<0.0001). The median lengths of PFS of lenvatinib and placebo were 18.3 and 3.6 months, respectively.
Secondary endpoints of the study included overall response rate, overall survival and safety. The study enrolled 392 patients in over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group. Eisai expects to file for lenvatinib in the next few months.
Sanofi US launched an authorized generic version of Eloxatin (oxaliplatin injection) through Winthrop US, the company’s generics division. Sanofi’s authorized generic version is the same formulation as the original drug, for which the company holds the original patent.
Eloxatin is a platinum-based drug used in combination with infusional 5-fluorouracil/leucovorin. This treatment is indicated for treatment of advanced colorectal cancer or as adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. The authorized generic version of Eloxatin will be available in the same sizes: 50 mg and 100 mg single-use vials.
