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.
of Abraxane in the Indian market is expected in 2008 following the completion
of the appropriate importation certifications.
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
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.
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.
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.
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.
therapy should have included an anthracycline unless clinically contraindicated.
The most serious adverse events associated with Abraxane in the randomized metastatic
breast cancer study for 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.