New Lung Cancer Drug Wins Early Approval, Reports Sky-High Cost

New Lung Cancer Drug Wins Early Approval, Reports Sky-High Cost | Pintas & Mullins Law Firm

In an unusual move, the FDA recently announced its approval of a lung cancer drug, Tagrisso, under its fast-track program. The drug treats a specific type of lung cancer categorized by a genetic mutation that causes tumors to resist traditional therapies. Lung cancer lawyers at Pintas & Mullins Law Firm discuss this new drug, the patients eligible to receive it, and it’s astronomically high cost below.

Tagrisso, manufactured by AstraZeneca, will cost $12,750 for a month's supply. Financial experts project the drug to generate more than $1 billion in sales in 2020, though AstraZeneca expects peak sales of $3 billion per year. The company claims patients with adequate insurance will not pay more than $25 per month. If a patients' insurance does not cover Tagrisso, the company will direct the individual to an organization that supports cancer patients.

More practically, experts point to the fast-approaching patent expirations for Crestor and Nexium, two of AstraZeneca'€™s most popular drugs. Industry insiders say the incredibly high price tag for Tagrisso is meant to offset the financial losses of these patent expirations.

Tagrisso targets a genetic mutation (epidermal growth factor receptor T790M) that helps tumors escape cancer treatments. It is the first drug approved to treat this specific type of lung cancer patient, whose disease worsens after initial therapies. Tagrisso won approval two years after starting clinical trials; normally, it takes the FDA roughly 12 years to approve a drug after clinical trials begin.

The FDA has five categories for its urgent approval process: fast track, breakthrough, orphan drug, accelerated, and priority review. Tagrisso qualified for all five. More details on each of these categories and the approval process in general can be found here, on the FDA website.

In Tagrisso’s Phase II trials, 59% of patients showed tumor size reduction. Less than 4% reported side effects, and the most common reactions were rash and diarrhea. The drug has already been shipped to special cancer pharmacies throughout the country, and are not available in traditional chain pharmacies like Walgreens.

Targeted Lung Cancer Therapies

Tagrisso is a once-daily tablet targeted to treat a specific type of lung cancer. This type of targeted therapy is growing in cancer research and development; as experts learn more about the changes that occur in lung cancer cells, they are able to invent new drugs to specifically target these changes. Targeted drugs like Tagrisso and Iressa, which we wrote about here, are not like traditional chemotherapy drugs. These pills have fewer side effects and are often used alone after chemotherapies fail to work.

Chemotherapy kills all cells in its path, whether they are cancer or normal tissue. Targeted therapies attack or block very specific cells for a more advanced and unique fight against the cancer. These therapies are often used in later-stage cancers that cannot be cured by surgery.

Our team of lung cancer lawyers continually updates this blog on new and innovative cancer treatments. If you or someone you love has been diagnosed with lung cancer, contact our firm for a free case review. You may be entitled to significant compensation for your medical bills, emotional distress, time away from work, or loss of a loved one.