Celgene's Abraxane wins another OK in Europe

Celgene's ($CELG) Abraxane is one of those cancer fighters that has proven effective against many forms of cancer, and so the company has sought approvals far and wide, sometimes successfully and other times not. Now it has been recommended in Europe to treat lung cancer.

Already approved in Europe for breast cancer and pancreatic cancer, the New Jersey-based company today reported that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending Abraxane in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

It is the most common form of the disease, accounting for 85% to 90% of cases. In a study comparing it to patients receiving chemo and paclitaxel, the response rate of those taking Abraxane was 33%, compared with 25% in the control arm.

"Progress in lung cancer will come first from early diagnosis with patients presenting promptly with symptoms and second, with new drugs that are well tolerated and improve on current therapies. Incremental steps can lead to a meaningful impact on patients and society, given the frequency and aggressiveness of lung cancer," Dr. Mary O'Brien of The Royal Marsden NHS Foundation Trust, U.K., said in the announcement.

CHMP's recommendations are generally followed by the European Commission, which generally comes a couple of months later. That will apply to 28 countries.

Celgene had a different reception when trying to convince NICE to recommend use of the drug in the U.K. on pancreatic cancer. The hangup there was on price, not effectiveness. Earlier this month the cost watchdog reiterated an earlier finding that the drug was too expensive.

Celgene has a host of other cancer drugs, including some very successful new ones, that have generated strong sales. Abraxane, however, has been a workhorse for the drugmaker. In Q3, Celgene said that sales of Abraxane were $212 million, up 25%, with U.S. sales of $151 million and international sales of $61 million. The international number was a 62% leap.

- here's the announcement

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.