FDA Approves Abraxane for NSCLC and expands indication for Actemra

The US Food and Drug Administration on Friday approved biotech firm Celgene’s (Nasdaq: CELG) Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Abraxane is already approved and marketed for second-line metastatic breast cancer treatment and generated sales of $214 million in the first half of this year. FDA approval for NSCLC opens up a major new source of revenue for Celgene. Barclays analysts have estimated peak potential sales for lung cancer at $110 million a year, according to a report by Reuters. The regulatory green light should also certainly please the owners of the drug’s original developer Abraxis, which Celgene acquired for $2.9 billion, who were in line for $650 million in milestones based on additional approvals, it noted. Celgene’s shares rose as much as 2.6% but closed Friday trading just 0.9% higher at $78.42.

“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Mark Socinski, director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of the Abraxane Phase II and Phase III lung cancer trials. “The FDA approval of Abraxane is exciting for health care professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years,” De Socinski added.