Patients suffering from breast cancer have been making a case for the Foods and Drugs Administration to approve Avastin as a prescribed medication for treating the illness. These presentations were made on the first day of the two-day hearing under progress. Genetech, which manufactures Avastin, is working to convince the FDA to reverse its December decision revoking the drug as a medicine to treat advance breast cancer.
The decision was made in December
The FDA had made the decision to cancel Avastin’s approval as an anti-cancer treatment drug in December. The officials said that the decision of the revocation was a result of analyzing the studies conducted during four separate clinical trials. The studies showed that the drug was neither effective to prolong the lives of patients diagnosed with metastatic breast cancer nor was effective in slowing down the progress of the illness. Avastin in combination with paclitaxel was approved in 2008 as a drug to treat breast cancer under the FDA’s accelerated approval program.
Events leading to the FDA revoking its earlier approval
The drug Avastin was approved under the accelerated program, which is a system that enables medications for serious illnesses to reach the market quicker but is required to undergo further research. According to the FDA officials, none of the studies conducted since its approval has found Avastin to be safe or effective. None of the five clinical trials undertaken since 2008 has shown that the medicine is effective in prolonging life or improving the life of patients. Moreover, the studies have also failed to show a slow-down in the spread of the tumor in patients. Dr. Richard Pazdur said that the FDA required only one research that showed positive results to enable the agency to reconsider its decision to cancel the drug’s approval.
Demonstration against the FDA decision
Although, FDA has cancelled the drug’s approval as a breast cancer treatment, the medicine will be available for treating other cancers. This will enable physicians to prescribe Avastin as an off-label medicine but the cost of this drug will not be covered under medical insurance. Therefore, it will make the treatment beyond the reach of patients as the medication costs roughly $88000 per annum. Several patients, their family members, physicians, and advocated made a representation to the FDA to reconsider its decision. Moreover, patients diagnosed with other types of cancers, such ovarian, kidney, colon, and melanoma were present to advocate the case for Avastin.