Biotech Values

[DewDiligence]

FDA Approves Tarceva for NSCLC ‘Maintenance’ Therapy Following Platinum-Based Chemo

[The “maintenance” indication is neither the first-line setting nor the second-line setting, but is rather like the 1.5th-line setting. LLY’s Alimta is also approved for NSCLC maintenance therapy, but only for non-squamous NSCLC. Tarceva’s approval for both the squamous and non-squamous subgroups thus gives Roche’s sales reps something positive to say, and these sales reps will need all the help they can get because Tarceva’s efficacy in the maintenance setting was marginal and was not coordinated with gene-variant testing.

In Dec 2009, ODAC voted 12-1 *against* Tarceva’s approval in this setting (#msg-44608619), but the FDA ignored the panel’s advice. Tareceva was approved in the NSCLC maintenance setting by the EU’s CHMP in Mar 2010 (#msg-48042138) and is awaiting formal rubber-stamping by the EU Commission. I doubt that individual EU countries will reimburse for Tarceva use in this indication, however.]

http://finance.yahoo.com/news/FDA-Approves-Tarceva-as-a-bw-3008303725.html?x=0&.v=1

›First Maintenance Therapy Approved for People With Either Squamous or Non-Squamous NSCLC

Friday April 16, 2010, 8:33 pm EDT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved the daily pill Tarceva® (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

“We hope this approval will help more people fight the leading cause of cancer death in the United States,” said Hal Barron, executive vice president, Global Development and chief medical officer. “Tarceva is the first oral maintenance option for people with advanced NSCLC who want to continue treating their cancer before it grows or spreads again.”

The new approval for Tarceva was based on data from the pivotal Phase III SATURN study. SATURN showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy significantly extended overall survival (OS) and significantly improved the time people with advanced NSCLC lived without the disease getting worse (progression-free survival, PFS), including people with either squamous or non-squamous NSCLC, compared with placebo. The goal of maintenance therapy, a new approach in lung cancer, is to provide an active treatment for people whose disease either responded to, or was stable, following initial chemotherapy before their cancer worsens. Many people are unable to receive further treatment after their cancer grows or spreads because of rapid cancer growth and worsening symptoms.

Tarceva is already FDA-approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy. Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.

About SATURN

SATURN was an international, placebo-controlled, randomized, double-blind, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress. PFS was defined as the length of time from randomization to disease progression or death from any cause.

• OS was significantly improved by 23 percent with Tarceva compared to placebo (hazard ratio=0.81, 19 percent reduction in the risk of death, p=0.0088).

• People who received Tarceva had a 41 percent improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo (hazard ratio=0.71, 29 percent reduction in the risk of cancer progression or death, p<0.0001).

• The most commonly reported adverse events in patients who received Tarceva as maintenance therapy were rash (49 percent) and diarrhea (20 percent). Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively. There were no cases of Grade 4 rash or diarrhea.

About Tarceva

Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer. The way Tarceva works to treat cancer is not fully known.

In addition to its indications in advanced NSCLC, Tarceva is also prescribed in combination with gemcitabine for patients with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed, and who have not received previous chemotherapy.‹