New Lung Cancer Drug Approved

New Lung Cancer Drug Approved | Pintas & Mullins Law Firm

Our team of lung cancer lawyers strives to update this blog with the latest news and developments in lung cancer treatments. We report that a new drug for non-small cell lung cancer was recently approved as a first-line treatment, along with a companion diagnostic test.

First-line therapies – also called primary treatments or induction therapies – are accepted as the best treatments for a disease; if it does not cure the disease or results in severe side effects, other therapies may be added or replaced.

On July 13, 2015 the FDA announced its approval of Iressa (gefitinib) as a first-line treatment for patients with a certain type of non-small cell lung cancer (NSCLC) characterized by gene mutations. The gene mutations cause tumors to harbor epidermal growth factor receptors, and can be detected by an FDA-approved test. NSCLC is the most common type of lung cancer and the epidermal growth factor mutations are present in about 10% of these tumors.

Iressa blocks proteins that promote the development of cancer cells with these mutations. This is a highly-targeted drug to treat select lung cancer patients. Iressa was tested on more than 100 patients at several different cancer centers who were diagnosed with untreated, metastatic, mutation-positive NSCLC. Participants received 250 mg of Iressa each day. About half of these patients showed tumor shrinkage, lasting for about six months.

The kit to detect the specific gene mutation, EGFR RGQ PCR Kit, was also approved by the FDA to enable doctors to identify which NSCLC patients were eligible for Iressa.

Iressa can cause serious side effects in patients, including liver damage, ocular disorders, lung disease, and gastrointestinal perforation. The most common side effects were diarrhea and skin reactions.

In May 2015, Roche announced positive results for one of its investigational medicines meant for NSCLC patients with a different type of mutation. The drug, alectinib, shrank tumors in patients with anaplastic lymphoma kinase inhibitor (ALK) non-small cell lung cancer. The drug also shrank tumors in patients whose cancer had spread to the central nervous system.

ALK-positive lung cancer leads to an uncontrolled spread of cancer cells, often into the brain, making it a difficult disease to treat. The ALK mutation was first discovered in 2007, and is present in about 5% of NSCLC patients. ALK mutations are more common in younger patients (under 40), patients who never smoked, women, and patients with East Asian ethnicity.

Roche plans to submit its data to the FDA later in 2015 for approval as treatment for advanced ALK-positive NSCLC.

Patients with lung cancer should be aware of these drugs for specific genetic mutations and request testing. While the use of detection kits is increasing, there are still many patients who are never offered the test. It is critical that patients do some of their own research, get second opinions, and ask doctors questions about their specific cancer type and individualized treatment options.

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