Pfizer Gets Nod For Cancer Drug Xalkori

By Jenn Loro - 13 Mar '16 13:32PM

Federal health authorities in the US have just given pharmaceutical giant Pfizer the green signal to expand the scope of treatment of its drug known as Xalkori to include a rare type of advanced non-small-cell lung cancer- the first and so far the only therapy developed for such condition.

The therapy, medically referred to as crizotinib, was initially developed and subsequently okayed by the US Food and Drug Administration in 2011 as a recommended medication for about 5% of non-small cell lung cancer patients who had shown signs of ALK genetic alterations in cancer tumors.

However, rare lung cancer cell mutations demand an expanded application of Xalkori to treat about 1% of patients diagnosed with metastatic non-small cell lung cancer with tumors exhibiting ROS-1 gene mutation.

"Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare. The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult-to-treat ROS-1 gene mutation," said Dr. Richard Pazdur of FDA's Center for Drug Evaluation and Research as quoted in a published report.

American Cancer Society indicated that lung cancer is the biggest killer among men and women in the US responsible for 1 in every 4 cancer deaths nationwide. As of this year alone, 224,390 new lung cancer cases have been reported to health authorities while 158,080 (85,920 in men and 72,160 in women) have already died from this dreadful but largely preventable disease.

Meanwhile, markets remain uncertain over the possible outcomes of Pfizer's planned merger with a smaller New Jersey-based drug company Allergan. Critics argue that the planned convergence of the two pharmaceutical firms would allow Pfizer to shift its tax commitments elsewhere. Allergan has already shifted its tax abode to dodge US-based taxation. A report, however, suggests that analysts and observers remain cautious in the event of an anti-trust move by federal authorities to rein in 'tax dodgers'.

In another development, global medical aid organization Doctors Without Borders (also known as Medicins Sans Frontieres or MSF) has just filed a formal patent opposition against Pfizer's application for Indian patent for its pneumonia vaccine which the group fears could make the vaccine economically inaccessible to poor children once the vaccine gets a nod from health authorities in India.

"The pneumonia vaccine is the world's best-selling vaccine, and last year alone, Pfizer brought in more than $6 billion in sales just for this product. Meanwhile, many developing countries, where millions of children risk getting pneumonia, simply can't afford it... other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges," remarked Dr. Manica Balasegaram of MSF's Access Campaign in an official statement as mentioned in a news report.