Hodgkins lymphoma has not had a new drug for its treatment since 1977.Here is a new drug acting in a novel way to bring remission in resistant ACLC and Hodgkins Lymphoma.

Team@CMHF

An FDA advisory panel voted unanimously to recommend accelerated approval for an investigational drug to treat Hodgkin lymphoma in patients who have already had a stem cell transplant, and for patients with relapsed or resistant systemic anaplastic large cell lymphoma.

Brentuximab vedotin, which Seattle Genetics will market as Adcetris, combines an antibody with a chemotherapy drug to treat the rare blood cancer in a novel way. The antibody binds to the CD30-positive Reed-Sternberg cells that are characteristic of the disease, while the drug — monomethyl auristatin — then attacks the internal structure of the cells.

The Oncologic Drugs Advisory Committee based its 10-0 vote on the Hodgkin lymphoma indication on the company’s open-label trial in which three-quarters of the patients treated with brentuximab vedotin had at least some reduction in tumor burden and more than a third had a complete remission.

More than one-third of patients had complete remission, and 40% had partial remission. Overall, 94% patients had at least some tumor reduction.
Later in the day, the advisory committee again voted 10-0 that the drug should also be approved for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

The main adverse event with brentuximab vedotin was peripheral neuropathy. Fatigue and nausea were also common.
There have been no new agents approved for the treatment of Hodgkin lymphoma since 1977 and there are no standard or approved therapies for patients who are refractory or relapsed after stem cell transplant.

The FDA is not required to follow the advice of its advisory committees, but it often does.
If Seattle Genetics receives accelerated approval, it still has to perform a trial confirming that the drug works and is safe. The agency is expected to make its final decision by August 30.

Ref:  http://www.medpagetoday.com/HematologyOncology/Lymphoma/27543?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&userid=333280