Drug Controller-General approves Biocon - Abraxis BioScience breast cancer drug Abraxane
By Our Corporate Bureau | 19 Oct 2007
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Mumbai: Biocon Ltd has received approval from the Drug Controller-General of India (DCGI) to market breast cancer drug Abraxane injectible suspension in India, Biocon and Abraxis BioScience Inc said in a joint statement.
Marketing of Abraxane in the Indian market is expected in 2008 following the completion of the appropriate importation certifications.
Under the terms of the agreement between Biocon and Abraxis, announced in August this year, Biocon will have the right to market the drug in India, Pakistan, Bangladesh, Sri Lanka, the UAE, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries.
On 15 October 2007 Abraxis BioScience announced having reached a definitive agreement with the US Food and Drug Administration (FDA) under the 'special protocol assessment' (SPA) process on the Phase III trial design of the company's pivotal study with Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting.
In the agreement, the FDA has determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission.
The Phase III pivotal trial is a randomised, open-label trial comparing weekly 100 mg/m2 Abraxane (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol(R) (paclitaxel) injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate and enrollment of this trial will begin immediately.
The FDA's SPA process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval.
The US Food and Drug Administration approved Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated. The most serious adverse events associated with Abraxane in the randomized metastatic breast cancer study on which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia / arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction.
Marketing of Abraxane in the Indian market is expected in 2008 following the completion of the appropriate importation certifications.
Under the terms of the agreement between Biocon and Abraxis, announced in August this year, Biocon will have the right to market the drug in India, Pakistan, Bangladesh, Sri Lanka, the UAE, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries.
On 15 October 2007 Abraxis BioScience announced having reached a definitive agreement with the US Food and Drug Administration (FDA) under the 'special protocol assessment' (SPA) process on the Phase III trial design of the company's pivotal study with Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting.
In the agreement, the FDA has determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission.
The Phase III pivotal trial is a randomised, open-label trial comparing weekly 100 mg/m2 Abraxane (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol(R) (paclitaxel) injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate and enrollment of this trial will begin immediately.
The FDA's SPA process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval.
The US Food and Drug Administration approved Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated. The most serious adverse events associated with Abraxane in the randomized metastatic breast cancer study on which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia / arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction.
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