Seattle Genetics’ Antibody-Drug Conjugate Technology Utilized in Genentech’s Polivy, Now Approved by FDA
June 10 2019 - 12:51PM
Business Wire
-Approval Triggers Milestone Payment and
Royalties on Worldwide Net Sales-
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced U.S. Food
and Drug Administration (FDA) approval of Polivy™ (polatuzumab
vedotin-piiq), which is an antibody-drug conjugate (ADC) targeting
CD79b that utilizes Seattle Genetics’ technology. Polivy was
developed and will be commercialized by Genentech, a member of the
Roche Group. It was approved in combination with bendamustine plus
Rituxan® (rituximab) (BR) for the treatment of adults with relapsed
or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have
received at least two prior therapies. Polivy previously received
FDA Breakthrough Therapy Designation, and was approved more than
two months ahead of the Prescription Drug User Fee Act (PDUFA)
action date of August 19, 2019.
“The approval of Polivy under our collaboration with Genentech
is an important milestone for Seattle Genetics as it extends the
reach of our technology to more patients with significant unmet
medical needs,” said Clay Siegall, Ph.D., President and Chief
Executive Officer of Seattle Genetics. “This approval, along with
our own internal ADCs in development and those of other
collaborators, such as GlaxoSmithKline, highlights that ADCs
continue to grow as an important therapeutic approach to treating
both hematologic malignancies and solid tumors.”
Polivy was granted PRIME (PRIority MEdicines) designation by the
European Medicines Agency (EMA) for the treatment of patients with
R/R DLBCL. PRIME is a designation implemented by the EMA to support
data generation and development plans for promising medicines,
providing a pathway for accelerated evaluation by the agency.
Polivy is also being investigated by Genentech in several ongoing
clinical trials for the treatment of non-Hodgkin lymphoma (NHL),
including frontline DLBCL.
Seattle Genetics’ ADC technology combines the specificity of
monoclonal antibodies, innovative linker systems and potent
cell-killing agents to treat cancer. The technology has been
licensed to several companies, including Genentech and
GlaxoSmithKline. Under the terms of these agreements, each company
has rights to use the technology with antibodies against selected
targets. The licensee is responsible for research, product
development, manufacturing and commercialization. Seattle Genetics
is entitled to receive fees, progress-dependent milestone payments
and royalties on worldwide net sales of any resulting ADC
products.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful
difference in people’s lives. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. The company is
headquartered in Bothell, Washington, and has a European
office in Switzerland. For more information on our robust
pipeline, visit www.seattlegenetics.com and follow
@SeattleGenetics on Twitter.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company’s
transition into a multi-product global oncology company, the
therapeutic importance of ADCs, the commercial potential of Polivy
including the potential for its approval for use in the European
Economic Area for the treatment of R/R DLBCL and the potential for
its approval in the United States and other territories in
additional indications, the potential for Genentech and
GlaxoSmithKline to pay the company milestones and royalties, as
well as other statements that are not historical facts. 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 the risks and uncertainties
associated with commercializing Polivy due to competition,
unexpected adverse events, regulatory action, reimbursement, market
adoption by physicians or other factors. Genentech may also be
delayed or unsuccessful in its planned clinical trial initiations,
the enrollment in and conduct of its clinical trials, obtaining
data from clinical trials, planned regulatory submissions, and
regulatory approvals in each case for a variety of reasons
including the difficulty and uncertainty of pharmaceutical product
development, negative or disappointing clinical trial results,
unexpected adverse events or regulatory discussions or actions and
the inherent uncertainty associated with the regulatory approval
process. More information about the risks and uncertainties faced
by Seattle Genetics is contained under the caption “Risk
Factors” in the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019 filed with
the Securities and Exchange Commission. Seattle
Genetics disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise except as required by
applicable law.
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Investors:Peggy Pinkston(425) 527-4160ppinkston@seagen.com
Media:Monique Greer(425) 527-4641mgreer@seagen.com
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