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FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma
August 16, 2017 at 8:00 AM EDT
-Supplemental BLA Based on Clinical Trial Results from the Phase 3 ALCANZA and Phase 2 Investigator-Sponsored Studies in CTCL-
-FDA Previously Granted ADCETRIS Breakthrough Therapy Designation in CTCL-
-PDUFA Action Date is
“The FDA’s filing of our supplemental BLA with Priority Review status
represents a significant milestone towards our goal of making ADCETRIS
available to CTCL patients who require systemic therapy,” said
The supplemental BLA is primarily based on positive results from a phase
3 trial called ALCANZA that were presented at the 58th
Based on discussions with the
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of
non-Hodgkin lymphoma that primarily involve the skin. According to the
The standard treatment for systemically pretreated CTCL includes skin-directed therapies, radiation and systemic therapies. The systemic therapies currently approved for treatment have demonstrated 30 to 45 percent objective response rates, with low complete response rates.
ADCETRIS is being evaluated broadly in more than 70 ongoing clinical
trials, including four phase 3 studies: the ECHELON-1 trial in frontline
classical Hodgkin lymphoma from which positive top-line results were
recently reported, the ongoing ECHELON-2 trial in frontline mature
T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell
lymphoma that supported the supplemental BLA to the
ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.
ADCETRIS for intravenous injection has received approval from the
ADCETRIS was granted conditional marketing authorization by the
ADCETRIS has received marketing authorization by regulatory authorities in 67 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
In two uncontrolled single-arm trials of ADCETRIS as monotherapy in 160 patients with relapsed classical HL and sALCL, the most common adverse reactions (≥20%), regardless of causality, were: neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.
In a placebo-controlled trial of ADCETRIS in 329 patients with classical HL at high risk of relapse or progression post-auto-HSCT, the most common adverse reactions (≥20%) in the ADCETRIS-treatment arm (167 patients), regardless of causality, were: neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use.
Advise females of reproductive potential to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the
therapeutic potential, and the possibility of market approval of
ADCETRIS (brentuximab vedotin) for uses including CTCL and other
CD30-expressing lymphomas for which ADCETRIS has not received regulatory
approval. Actual results or developments may differ materially from
those projected or implied in these forward-looking statements. Factors
that may cause such a difference include that the supplemental BLA
submission will not be sufficient to gain marketing approval in