Approval Based on Significantly Improved Overall Response Rates in all Patients Regardless of Histology
Adds a New Therapeutic Option for Patients with Lung Cancer, the Leading Cause of Cancer Deaths in the United States
SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved 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, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Dr. Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of ABRAXANE phase II and phase III lung cancer trials. “The FDA approval of ABRAXANE is exciting for healthcare 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.”
The ABRAXANE sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study where patients with advanced non-small cell lung cancer (NSCLC) received either ABRAXANE (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6) (n=531). The study met its primary end-point demonstrating a statistically significantly higher overall response rate for patients in the ABRAXANE arm compared to those in the paclitaxel arm (33% vs 25%).
In the phase III study, ABRAXANE demonstrated a higher overall response rate as compared to paclitaxel for squamous cell carcinoma (41% vs. 24%) and large cell carcinoma (33% vs. 15%). ABRAXANE achieved a similar overall response rate to paclitaxel in patients with carcinoma/adenocarcinoma (26% vs. 27%).
The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
Additional regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.
This approval marks the second indication for ABRAXANE in the United States. In the United States, ABRAXANE was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated 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.
ABRAXANE is indicated 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.
Important Safety Information
WARNING - NEUTROPENIA
WARNINGS AND PRECAUTIONS
Use in Pregnancy: Pregnancy Category D
Use in Men
Randomized Metastatic Breast Cancer (MBC) Study
Non-Small Cell Lung (NSCLC) Cancer Study
Post-Marketing Experience with ABRAXANE and other Paclitaxel Formulations
USE IN SPECIFIC POPULATIONS
DOSAGE AND ADMINISTRATION
Please see full Prescribing Information, including Boxed WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
About Non-small cell lung cancer
Non-small cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small-cell lung carcinoma (SCLC). NSCLC is classified into two major types: squamous cell carcinoma, which accounts for 25-30% of all NSCLC cases and non-squamous cell carcinoma, the most common lung cancer in the U.S. When possible, lung cancer is primarily treated by surgical resection with curative intent. Chemotherapy may be used both pre-operatively (so-called "neoadjuvant chemotherapy") and post-operatively ("adjuvant chemotherapy") and as first-line for more advanced stages of lung cancer.
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.
In the United States, ABRAXANE was first approved in January 2005 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. ABRAXANE is also available in Europe, Canada, Russia, Australia, New Zealand, India, South Korea, Bhutan, Nepal, United Arab Emirates and China for the treatment of metastatic breast cancer.
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.
For the full prescribing information for ABRAXANE please visit http://www.abraxane.com.
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: pancreatic, metastatic melanoma, bladder, ovarian, and expanded applications for breast cancer.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
Source: Celgene Corporation