|Seattle Genetics Announces ADCETRIS BLA Accepted for Filing by the FDA; Ligand Partner Rib-X Initiates Phase 3 Trial of Delafloxacin IV|
|By Staff and Wire Reports|
|Tuesday, 14 May 2013 18:56|
Seattle Genetics (NASDAQ: SGEN) announced the U.S. FDA has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.
“Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The FDA's acceptance of our sBLA submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome.”
The sBLA is based on results from a phase 2 clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm evaluated extended treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase 2 trial.
Preliminary data from this trial were previously reported at the 2011 American Society of Hematology (ASH) Annual Meeting and at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting. Highlights include:
Retreatment: Of 23 evaluable patients who were retreated with ADCETRIS, 70 percent (16 of 23) achieved an objective response, including nine complete remissions and seven partial remissions. Median duration of retreatment objective response was 8.8 months. ADCETRIS was generally well tolerated in the retreatment setting. The most common adverse events were peripheral neuropathy (46 percent), nausea (42 percent), fatigue (38 percent), diarrhea (33 percent) and fever (29 percent), the majority of which were Grade 1 or 2. Extended duration of treatment:
Extended treatment data were reported from 17 patients with a median duration of treatment of 17.3 months (approximately 24 cycles of every three-week dosing). The overall objective response rate with extended treatment was 88 percent, including 76 percent complete remissions and 12 percent partial remissions. ADCETRIS was generally well tolerated in this setting, with the most common adverse events being peripheral neuropathy (71 percent), upper respiratory infection (53 percent) and fatigue (47 percent). Adverse events were effectively managed by dose delays and reductions, with less than ten percent of doses delayed or reduced. All events of peripheral neuropathy and upper respiratory infection were Grade 1 and 2 and one patient experienced a Grade 3 fatigue event. ADCETRIS is currently not approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced its partner Rib-X Pharmaceuticals, Inc. has initiated a Phase 3 clinical trial of a Captisol-enabled™ intravenous (IV) formulation of delafloxacin for the first-line treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by MRSA. Under the terms of a license and supply agreement, Ligand has earned a $500,000 milestone payment.
“Captisol is enabling yet another medically important late-stage candidate, and continues to deliver significant value to the business,” commented Matthew W. Foehr, Executive Vice President and Chief Operating Officer of Ligand. “Rib-X is an excellent partner, and we are confident in their ability to develop this late-stage asset. Additionally, today's announcement further reinforces the strength of Ligand's business model and the depth and quality of our portfolio of over 85 partnered programs.”
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