The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 106 entries through 3/27/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 139 entries through 3/27/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Roche (RHHBY.PK): PDUFA date is 5/5/09 for Avastin (bevacizumab) sBLA - brain cancer (relapsed glioblastoma) - 3/31/09 Advisory Panel Meeting by FDA Oncologic Drug Advisory Committee - originally filed by Genentech. On 3/27/09, FDA filings were released ahead of the advisory panel meeting, with a summary included below.
FDA documents suggest that it is difficult to tell how well brain cancer patients responded to Avastin in early studies. Also, among patients who exhibited a positive treatment effect on their tumors, the FDA documents suggest it is unclear whether that was from the effect of Avastin or from other issues, adding that the agency would seek advice from its panel of outside experts.
Glioblastomas are the most aggressive type of brain tumor, killing about 10,000 people each year, with current treatment options that include chemotherapy and radiation. Genentech also released its own documents today which state that Avastin data shows improvements in patients with brain cancer and that it was starting a larger study that would offer more information in 2014.
Avastin is a type of anti-angiogenic drug that restricts the rapid growth of blood vessels that spur tumor growth. One study of 167 patients found a median response rate of 4.2 months among those who saw a tumor reduced, while a second study of 56 patients found a median response of 3.9 months, according to the FDA. Avastin saw U.S. net sales of $2.7B in 2008. Some 19,000 cases of brain tumors are diagnosed each year, the company has said, citing government stats.
2.) Spectrum Pharma (SPPI): The FDA accepted Spectrum's sNDA for FUSILEV (levoleucovorin for injection) on 3/26/09 for use in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date deadline is 10/8/09. FUSILEV was approved on 3/7/08 for rescue therapy after high-dose methotrexate treatment in osteosarcoma (a type of bone cancer).
3.) Dyax Corp. (DYAX): Dyax Corp. (DYAX) announced 3/26/09 that it has received a complete response letter (CRL) from the FDA for its BLA seeking approval of DX-88 (ecallantide) in the treatment of acute attacks of hereditary angioedema (HAE).
The FDA has requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. No additional clinical trials are necessary for approval of DX-88, and the FDA will issue either a Class I (60-day) or Class II (six-month) review designation after Dyax submits its response to the requests outlined in the CRL.
4.) Osiris Therapeutics (OSIR): OSIR announced on 3/27/09 that it has decided to halt enrollment at 210 patients in a Phase 3 trial evaluating Prochymal for Crohn’s disease. The Company believes there is a design flaw in the trial resulting in significantly higher than expected placebo response rates. The decision was made after the trial’s final scheduled interim analysis showed that one of the two Prochymal dose arms had crossed a futility boundary. The dose arm was unlikely to achieve the primary endpoint of remission because of the high placebo response rate. This latest analysis continued to show no serious safety concerns with the therapy and safety was not a factor in the decision to stop enrollment.
The trial will remain blinded and OSIR expects a solid data package for use in designing future trials in Crohn’s disease and the data will also be used to bolster Prochymal’s safety database. The Prochymal Crohn’s program consists of two separate but related double blinded trials. The first trial evaluates patients’ initial response to two dose levels of Prochymal as compared to placebo. The trial was originally designed to enroll 270 subjects.
The potential trial design flaw may be related to the fact that patients responding to the initial therapy were eligible to participate in a second, longer-term trial evaluating Prochymal as a maintenance therapy. Because the current standard for determining response of Crohn’s patients to therapy is largely subjective, there may have been response bias to meet the eligibility requirements for continuation of therapy in the longer-term maintenance trial, according to the Company's press release today.
$2.02 (03/27/09)
