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Rituxan sBLA seeks NHL combo claim

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech's Horizon 2010 strategy progresses with the March 29 sBLA submission of Rituxan (rituximab) for front-line treatment of previously untreated non-Hodgkin's lymphoma in combination with two chemotherapeutic regimens. The application is based on two pivotal trials in 644 treatment-experienced patients and proposes use of Rituxan in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) regimens, or following CVP in responders. The submission follows two supplemental approvals for Rituxan in February: one for rheumatoid arthritis and an expansion of the biologic's front-line diffuse large B-cell, NHL indication (1Pharmaceutical Approvals Monthly March 2006, p. 14). The Horizon 2010 strategy calls for Genentech to gain FDA clearance for at least 15 new indications or products by 2010...

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Approvals In Brief

Erbitux for head and neck cancer: Bristol-Myers Squibb/ImClone's Erbitux (cetuximab) is cleared March 1 for use in combination with radiation therapy for treatment of "locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)" and as monotherapy for "patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed." The epidermal growth factor receptor inhibitor is the first agent approved for head and neck cancer that has shown a survival benefit, FDA notes. Erbitux previously was approved for treatment of colorectal cancer patients refractory to or intolerant of Pfizer's Camptosar (irinotecan). The per-unit cost of Erbitux could be modified if use is expanded to include treatment cycles of longer duration, ImClone says. The administration cycle for the head and neck cancer indication is eight weeks, in conjunction with radiation, and until progression/unacceptable toxicity for monotherapy, labeling states. Cetuximab currently is priced at about $19,000 for an eight-week cycle. The sBLA was filed Aug. 30 and received a priority review (1Pharmaceutical Approvals Monthly September 2005, In Brief)...

QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

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Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.





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