The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for Abraxane ( Paclitaxel formulated as albumin-bound nanoparticles, or Nab-paclitaxel ) 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.
The positive CHMP opinion was based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with stage IIIb/IV non-small cell lung cancer. The study compared Abraxane in combination with Carboplatin versus solvent-based Paclitaxel in combination with Carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
The primary efficacy endpoint, overall response rate, was significantly higher for patients in the Abraxane / Carboplatin arm at 33%, compared with patients in the control arm, at 25%.
The most common adverse reactions ( greater than or equal to 20% ) of Abraxane in combination with Carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.
Abraxane is an albumin-bound form of Paclitaxel that is manufactured using patented nab technology. Abraxane is formulated with albumin, a human protein, and is free of solvents.
Abraxane was first approved in January 2005 by the FDA ( Food and Drug Administration ) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated.
In Europe, Abraxane was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.
In October 2012, Abraxane was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with Carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
In September 2013, the FDA approved Abraxane as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with Gemcitabine.
In December 2013, Abraxane in combination with Gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Europe.
Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe.
Non-small cell lung cancer is the most common form of lung cancer, accounting for 85 to 90% of all cases.
The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer.
Treatment options generally include systemic chemotherapy or protein kinase inhibitors.
In the most advanced cases, only the symptoms of the disease can be managed. ( Xagena )
Source: Celgene, 2015