11 February 2019 - - US-based Seattle Genetics, Inc.'s (NASDAQ: SGEN) collaborator, Takeda Pharmaceutical Company Ltd., has received approval from the European Commission to extend the marketing authorisation for Adcetris (brentuximab vedotin) to include Adcetris in combination with AVD (Adriamycin, vinblastine and dacarbazine) in adults patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on December 13, 2018.

As a result, Seattle Genetics will receive a milestone payment from Takeda of USD 30m.

Adcetris is an antibody-drug conjugate directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival.

The marketing authorization for Adcetris is based on positive results from the ECHELON-1 phase 3 clinical trial that were presented in the Plenary Scientific Session at the 59th American Society of Hematology annual meeting in December 2017 with simultaneous publication in the New England Journal of Medicine.

In September 2018, the Japanese Ministry of Health, Labour and Welfare approved ADCETRIS in combination with AVD as a frontline treatment option for CD30-positive HL patients in Japan.

In March 2018, the US Food and Drug Administration approved Adcetris in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the ECHELON-1 phase 3 clinical trial.

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.

Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

Adcetris is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

The phase 3 CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.

Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E, 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-expressing tumor cells.