FDA information on Tarceva
FDA approved Tarceva for treatment of locally advanced or metastatic non-small cell lung cancer, after failure of at least one prior chemotherapy regime in November 2004. OSI, the manufacturers of the drug had anticipated late January as the deadline for the approval, however FDA’s approval came well before in time, making it one of the fastest approvals ever. It approved Tarceva in their “Pilot Program for Continuous Marketing Applications.” This pilot program was started keeping Tarceva like drugs in mind which demonstrated significant promise as a therapeutic advance over the conventional chemotherapy during the clinical trials, and hence given a Fast Track status.
A randomized double- blind, placebo- controlled pivotal Phase III trial of NSCLC patients with second and third line advance was carried out. The trial comprised of 731 advance-staged NSCLC patients who had undergone one or more chemotherapy regimes, which had failed to produce the desirable results. The conclusions were:
- The comparison between Tarceva, placebo and Iressa during this trial concluded that while Tarceva prolonged the NSCLC patient’s life by 6.7months placebo did the same for 4.7 months and Iressa just shrink the tumors with no increase in the life span. Other than this, 31.2% of patients taking Tarceva were alive after one year, versus 21.5% in the placebo arm.
- Tarceva also met its second milestone of the trial by
- delaying the time of symptom deterioration,
- improving progression free survival
- Increasing tumor response rate.
Post this Phase III trial of NSCLC patients with second and third line advance, FDA approved Tarceva to be used in combination with gemcitabine chemotherapy as a cure for locally advanced, inoperable or metastatic pancreatic cancer patients, who have not been administered any chemotherapy, in November 2005. Once again a randomized double- blind, placebo- controlled Phase III clinical study of Tarceva, in combination with gemcitabine chemotherapy was performed on 569 patients with unresectable locally advanced or metastatic pancreatic cancer. The conclusions were:
- Primary Milestone of improving overall survival rate by 23% was met.
- Patients receiving Tarceva in combination with gemcitabine chemotherapy were alive by 21% as compared to 19% patients receiving a combination of placebo with gemcitabine chemotherapy
- Hazard ratio=0.76 implied a significant improvement in progression free survival.
In April 2010, FDA approved Tarceva to be administered as a maintenance drug to NSCLC patients, whose cancer has not spread or grown after the initial treatment of chemotherapy. However, it was to be noted that NSCLC patients should not have used Tarceva along with certain types of chemotherapy.
Tarceva, not only had a lot of benefits over the other targeted drug, it also had fewer side effects than the conventional chemotherapy. Skin rashes and diarrhea were the most common side effects associated with this medicine. Rare and hardly reported but there had been cases of lung cancer, bleeding or clotting problems, thinning of stomach and intestine linings, kidney or liver related problems, heart attacks or strokes when Tarceva was used in combination with other drugs.