The FDA stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed. The FDA completed its five-week inspection of the Allston plant on 11/13/09 and provided Genzyme with a Form-483 outlining remaining deficiencies.
Genzyme's plan to address these deficiencies includes establishing additional internal controls and updating fill/finish capabilities in Allston, transferring additional filling activities to existing Genzyme contract manufacturers, and utilizing excess capacity at Genzyme's manufacturing facility in Waterford, Ireland, which is undergoing a major expansion with engineering runs scheduled to begin in early next year. This expansion will increase Genzyme's internal filling capacity by 4X.
Cerezyme (imiglucerase for injection) 400-unit vials, which supply over 80% of patients worldwide, will be filled exclusively in Waterford moving forward. Alglucosidase alfa 2000 L scale (Lumizyme) is no longer produced at the Allston facility and Genzyme is transitioning all patients worldwide to the product produced at a larger scale (4000 L) in the company's facility in Belgium with a request for a FDA meeting pending to discuss US approval for this facility.
On 7/13/09, OSI Pharma (NASDAQ: OSIP) announced that SATURN, a pivotal Phase 3 study of Tarceva (erlotinib), met a key secondary endpoint of extending overall survival in patients with advanced non-small cell lung cancer (NSCLC) who received Tarceva immediately after initial chemotherapy. A statistically significant improvement in overall survival was seen in this pre-planned final analysis of the total patient population. The overall survival data will be submitted to the FDA to support the supplemental New Drug Application (sNDA) for use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC that was submitted on 3/17/09 with an expected PDUFA action date of 1/18/10.
SATURN met its primary endpoint and showed patients with advanced NSCLC who received Tarceva as a first-line maintenance treatment had a 41% improvement in the time they lived without the disease advancing (progression-free survival or PFS) compared to placebo. On 11/16/09, OSIP announced that the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy on 12/16/09.
On 8/11/09, Wyeth, since acquired by Pfizer (NYSE: PFE), announced it received notice that the action date for the pending FDA review of its Biologics License Application (BLA) for Prevnar 13, (Pneumococcal 13-valent Conjugate Vaccine) has been extended from 9/30/09 to 12/30/09. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical and chemical properties of the product in late July. The Agency considered this to be a major amendment and therefore extended the PDUFA action date by three months. On 5/7/09, WYE announced that the FDA granted a priority (six-month) review for this BLA which was filed at the end of March 2009.
The proposed indication in the U.S. for Prevnar 13 is for the prevention of invasive pneumococcal disease (IPD) and otitis media (ear infections) caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010. On 11/18/09, the Vaccines and Related Biological Products Advisory Committee will review this BLA.
On 11/16/09, Seattle Genetics (NASDAQ: SGEN) announced that it has initiated a Phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company's proprietary technology. CD70 is expressed on a variety of solid tumors, including renal cell carcinoma, pancreatic, ovarian and lung cancers and glioblastoma (GBM / brain cancer) as well as multiple myeloma and several types of lymphoma. The single-agent Phase I study is designed to enroll up to 80 patients at multiple centers in the US.
The trial will evaluate the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75 in order to identify a dose and schedule for future clinical trials. SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic drug payload, monomethyl auristatin F (MMAF), using SGEN's proprietary technology. The ADC is designed to be stable in the bloodstream, but to release its payload upon internalization into CD70-expressing tumor cells, resulting in targeted cell-killing.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
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