Tarceva gets nod for maintenance treatment

pharmafile | March 22, 2010 | News story | Sales and Marketing Tarceva, lung cancer 

Tarceva looks set to gain approval in Europe to treat patients with non-small cell lung cancer whose disease remains stable after initial chemotherapy, after being passed by a key regulatory committee.

Roche’s drug is currently only licensed as a second-line treatment in patients for whom chemotherapy has failed. 

The recommendation from Europe’s CHMP is expected to lead to approval, which will mean the drug can be used much earlier.

The CHMP’s positive opinion is based on data from the phase III SATURN trial, which suggested Tarceva can delay disease progression and extend overall survival compared to placebo in a range of advanced non-small cell lung cancer (NSCLC) patients when given as a maintenance therapy after chemotherapy.

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Professor Federico Cappuzzo, head of the oncology unit at Livorno Hospital in Italy and principal investigator of the SATURN trial, said: “Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of many patients deteriorates rapidly.

“By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we can help more patients live longer without their disease getting worse.”

Tarceva (erlotinib) is also licensed to treat pancreatic cancer, and overall its sales rose 10% to 1.3 billion Swiss francs in 2009, with its use in NSCLC driving up revenues.

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