Seattle Genetics to produce Lymphoma drug FDA (Reuters)

LOS ANGELES (Reuters) – a key trial Seattle Genetics tests with the patients antibodies targeting cancer n Hodgkin Lymphoma, it was found that more than a third of them achieved the complete remission of their cancer.

The company also said it expects to produce drugs now, following the US regulatory authorities brentuximab vedotin (2) years from the date of the first quarter of patients either n Hodgkin Lymphoma or anaplastic large cell Lymphoma (ALCL) that have ceased responding to other therapies. The company had previously said it would take place in the first half of 2011, the consignment.

"Our goal should be submitted in the first quarter of the year, and can be placed on the market of an accelerated review in 2011," Seattle Genetics CEO Siegall told Reuters the telephone Clay in the interview.

The experiment to compare with another drug brentuximab vedotin, but similar patients full cancellation of the course is typically a single character, he said.

The company is developing Lymphoma drug Japanese Takeda Pharmaceutical Co., Ltd., which is discussed in the framework of the European regulatory authorities with a view to a possible first-half 2011 with the submission.

September Seattle Genetics had said that 75% of the patients had a trial for 102 maastaviennissä or tumor shrinkage at least 50%. The experiment involved in the patient, who had stopped responding are p standard cancer.

The entire results--is presented in the Hematology American Society on Sunday, Orlando, Florida at the annual meeting are included in some sort of State-of-the-art-tumor reduction, 94% of the patients.

Brentuximab vedotin link tumor targeting antibody cancer chemotherapy drug by reason of the fact that the aim is to set a limit on the number of side effects. It is designed for home, Antigen n Hodgkin Lymphoma, T-cell Lymphoma of types and other hematologic malignancies.

The experiment of patients responded to 29 weeks of the independent evaluation of drugs according to median. Among the patients ' response to achieve remission was the median duration not yet reached, approximately a one-year longitudinal monitoring.

Seattle Genetics said they saw a serious side-effects included neutropenia, or white blood cells at low levels (20% of patients), and the peripheral sensory neuropathy (8%), the low number of leukocytes (8%), and anemia (6%).

Siegall estimated that there are close to the variable or refractory patients with relapsed Hodgkin's lymphoma in the United States and ALCL.

Brentuximab vedotin ALCL patients in the mid-stage trial of the full results will be scheduled at the Conference on Tuesday in a presentation, hematology. Top-line results, as reported by the Seattle Genetics in October, showed that 86% of patients responded to the detection of antibodies against the trial of the drug.

The company also is studying the original treatment of Hodgkin Lymphoma, and maintenance therapy drug.

Leerink Swann is estimated at about $ 302 million in the form of a sales 2015 brentuximab vedotin.

(Editing by Steve Orlofsky)


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