Approved by FDA in 2005 for use in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer
Approve by FDA in 2004 for treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Swiss pharmaceutical company Roche Holding AG (ROG.VX) said it will start a new trial for Tarceva in lung cancer patients with a certain form of gene mutation, challenging a similar drug candidate from U.K.-rival AstraZeneca PLC (AZN) that got a positive European Union panel recommendation Thursday.
Roche said it was working with the Spanish Lung Cancer Group, or SLCG, on a trial to study Tarceva as a first therapy for patients with a mutation in the so called epidermal growth factor receptor, or EGFR, which plays an important role for the development of lung cancer.
The trial will evaluate whether Tarceva works better for the initial treatment of patients with such a mutation than chemotherapy.
The news comes only a day after the advisory panel of the E.U.'s drug regulator said it was recommending approval for AstraZeneca's lung cancer drug, Iressa.
AstraZeneca didn't say when it planned to launch the drug, but pointed out that the European Commission usually followed the recommendations by the advisory panel within 90 days.
Iressa works by inhibiting the tyrosine kinase enzyme in the EGFR, blocking the transmission of signals involved in the growth and spread of tumors.
A mutation in the EGFR is a characteristic occurring in 10% to 15% of lung cancers in Europe, and studies have shown that these types of tumors are particularly sensitive to Iressa.
Both drugs would be an alternative to chemotherapy - usually associated with side effects - as the first treatment in this group of lung cancer patients.
Tarceva, which has a relatively benign side-effect profile, has been on the market in Europe since 2005 for patients where at least one chemotherapy has failed to show results.
In prior trials, Tarceva has already shown "a dramatic response" to patients with mutations to the EGFR gene, Roche said.
Deutsche Bank analyst Michael Leuchten said a potential launch of Iressa in Europe won't pose a threat to Tarceva.
"Patients (with the gene mutation) get the same magnitude of benefit with Iressa at 250 milligrams daily that they do with Tarceva 150 mg daily, and with less significant adverse effects," Leuchten said in a note to customers. "So, we don't doubt that Iressa will find its place in the treatment of non-small cell lung cancer, but see little risk to the Tarceva franchise," wrote Leuchten, who rates Roche at buy with a 188 Swiss francs price target.
Tarceva: Mechanism of Action.
Tarceva notes:
Tarceva (generic name erlotinib) is a cancer chemotherapy medication. Erlotinib interferes with the growth of cancer cells and slows their growth and spread in the body. Tarceva is used in the treatment of non-small cell lung cancer, pancreatic cancer and several other types of cancer.
Tarceva side effects includes severe or persistent nausea, vomiting, loss of appetite, eye pain or irritation, skin rash, dryness, itching, acne, weakness, difficult in breathing, closing of the throat, swelling of lips/tongue/ face or hives.
Drugs like atazanavir, rifampin, clarithromycin, nefazodone, telithromycin may effect the performance of tarceva. Grapefruit and grapefruit juice may interact with this medicine and could lead to adverse effects.
It is recommended to take tarceva at least one hour before or two hours after eating. If an overdose of is suspected, seek emergency medical attention immediately. Consult doctor in case of missing dose.
Tarceva 150mg was approved by FDA in November 2004 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer. This medication is available in three strengths
25mg, 100mg, 150mg.
Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture.
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