Rociletinib Drug Info, Approval And Clinical Trials
A new drug for patients with EGFR T790M positive-metastatic small cell lung cancer has been recently approved by the U.S Food And Drug Administration (FDA). Rociletinib is the new drug for treating cancer patients with mutant epidermal lung cancer cell growth. This drug was first invented and developed by Clovis Oncology Inc., many tests were carried out to ensure the safety of using this drug. After many case-studies and laboratory experiments for this drug, the U.S Food And Drug Administration approved this drug to be used by patients suffering from non-small cell Lung Cancer.
Rociletinib is an oral drug that inhibits the epidermal cell growth factor of non-small cell lung cancer cells. The drug targets the activite mutations of L858R and Del19 found in EGFR lung cancer patients. Rociletinib oral pills were allowed to be tested on patients with non-small cell lung cancer in May 2014. In a clinical trial with Rociletinib, 416 EGFR-positive patients received 4 doses of rociletinib ranging between 500mg to 1000mg. Out of 416 patients, 119 patients received a 500mg dose of Rociletinib daily. About 85 percent of the patients were from the U.S. and the median average age was 64 years, 11 percent had a prior history of high blood sugar levels (diabetes), while 41 percent had CNS-metastases.
The clinical trial showed positive results in killing cancer cells in all patients with non-small lung cancer. The drug was most effective to patients who used the 500mg dose twice a day, patients who administered 1000mg twice a day experienced strong side effects that included fatigue, diarrhea and upset stomach. Patients who received the 500mg dose of the drug reported very few side effects and most of them experienced no serious side effects after intake of the drug. The results of the clinical trials concluded that patients with small-cell lung cancer should use the drug as administered by the physician or with a doctor’s prescription.
Before the U.S. Food And Drug Administration approved Rociletinib for treatment of lung cancer, many risks and benefits were carefully reviewed. The benefits of using Rociletinib overpowered its risks and side effects. Clovis Oncology Inc. was allowed to produce and manufacture the drug. Boards of the European nations have also approved Rociletinib for treatment of cancer in their countries. Even though the drug wasn’t tested for so many years, health practitioners and specialists believe that Rociletinib poses no threat for the future life of the patients.