FDA Approves Major New Lung Cancer Medication

Health regulators in the United States have indicated that they have granted approval to an advanced lung cancer medication.

The drug in question is produced by the pharmaceutical manufacturer Roche Holding, and addresses lung cancer in patients with a specific genetic mutation.

Roche Holding will be selling the drug, alectinib, under the brand name Alecensa.

The medication has been approved with the intention of treating patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Alecensa will be particularly effective in treating those patients within whom this disease has worsened after, or who could not tolerate, treatment with competitor Pfizer’s Xalkori.

There are hopes that the drug will now be approved for wider marketplaces as well, as Roche Holding looks to increase its share of the lung cancer pharmaceutical marketplace.

“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, head of the Food and Drug Administration’s Hematology and Oncology Products division, commented in an official statement.

Xalkori was seen as an advance in the field of personalised medicine as it was designed to treat only patients with the ALK genetic mutation.

This is a relatively tiny portion of overall cancer sufferers, with this specific group accounting for only 4% of NSCLC patients.

As competition hots up in this particular area of pharmaceuticals, it has been reported that Pfizer is also developing a drug for ALK.

The pharmaceutical heavyweight has had to acknowledge that many patients have stopped responding to its own products Xalkori, and Pfizer is attempting to develop an alternative remedy.

Pfizer has established itself as one of the 50 largest corporations in the world according to Forbes magazine, with a market capitalisation in excess of $200 billion.

The pharmaceutical lobby is famously one of the most influential groupings in the United States, and indeed the industry spends more on lobbying government than any other comparable industrial sector.

While the United States pharmaceutical industry unquestionably produces many valuable medicines, the country has also been criticised for its reliance on responding to illnesses with drugs, as opposed to addressing the cause of problems.

Indeed, the US has something of an addiction to popping pills, with the country one of only two in the world that allows the television advertising of drugs (the other being New Zealand).

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence of clinical benefit.

A confirmatory study is required to verify the benefit of Alecensa for it to gain full approval, the agency revealed.

There are an estimated 158,040 deaths from lung cancer annually in the United States (86,380 in men and 71,660 among women).

 

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