Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘Seattle Genetics’

This morning, Seattle Genetics announced that the expected fast track approval from the FDA has been forthcoming for brentuximab vedotin (Adcetris) following the recent unanimous ODAC voting in both refractory Hodgkin Lymphoma (HL) and Anaplastic Large Cell Lymphoma (ALCL).  Clearly, the company and the agency have come to agreement on the confirmatory trials as part of the condition of accelerated review.  The final prescribing information (PI) can be found on the Adcetris website.

For those of you looking for more information on Adcetris, please check out the related posts section below for previous reports on this novel ADC therapy.


Quite a few questions have hit my inbox recently from people wanting to know more about Antibody Drug Conjugates (ADCs) and how they work.

They basically consist of three things:

  1. Monoclonal antibody
  2. Linker
  3. Cytotoxic agent

Antibody Drug Conjugate (ADC)

Source: Roche

The goal is to create a new molecule that essentially is greater than the sum of its parts by making it more targeted, like a guided missile against the cancer cells.


I was delighted to see, amongst all the big news this morning on President Obama and Osama Bin Laden, that there was a little gem for Biotech – Seattle Genetics announced that the FDA have accepted their BLA filings for antibody drug conjugate (ADC), brentuximab vedotin, and awarded Priority status.  The company stated that the Prescription Drug User Fee Act (PDUFA) date is now set for August 30th, based on the Feb 28th filing date.

Two BLA filings were submitted, one for relapsed Hodgkin Lymphoma (HL) and another for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).  These two hematologic cancers share a commonality, ie CD30, which is the defining marker of the disease and the target for the ADC therapy.

There have been a number of interesting early phase compounds with new data being reported at American Society of Hematology (ASH) meeting this weekend, some of these will be described over the next few days.Seattle Genetics has a number of monoclonal antibodies in development for the treatment of hematologic malignancies.  One of them, SGN-35is an antibody conjugate that targets CD-30 cells and hence is being evaluated in CD-30 positive malignancies such as Hodgkins Lymphoma.  There was an interesting poster published here (PDF) at the ASH meeting.

Lintuzumab is a humanized monoclonal antibody that targets the CD33 antigen, which is expressed on a number of hematologic malignancies, including AML, myelodysplastic syndromes (MDS) and several myeloproliferative disorders.  Seattle Genetics recently reported data from a completed phase Ia dose-escalation clinical trial of lintuzumab demonstrating multiple complete responses at well-tolerated doses. In addition to the phase IIb clinical trial, the company is also conducting a phase Ib trial of single-agent lintuzumab in patients with AML or MDS and a phase I trial of lintuzumab in combination with Revlimid(R) (lenalidomide) for advanced MDS. 

The Independent Data Monitoring Committee (IDMC) has now completed a pre-specified safety review of data from the ongoing phase IIb trial of lintuzumab (SGN-33) in combination with low-dose cytarabine chemotherapy for older patients with acute myeloid leukemia (AML). 

After review of the collected data, the IDMC did not identify any safety concerns and has recommended that the trial continue per the protocol. This interim assessment was based upon a planned evaluation of safety data from the first 50 percent of patients randomized in the study who received at least one dose of treatment. The company has completed approximately two-thirds of the total target enrollment of 210 patients, and expects to report data in the first half of 2010. 

Another drug from the same company, SGN-40 (dacetuzumab), is being tested b-cell lymphomas (PDF of poster) and multiple myeloma and was snapped up early by Genentech in a licensing deal in 2007.  Seattle Genetics also has a monoclonal antibody in development for autoimmune diseases (SGN-70 and SGN-75), which target CD70.  The latter is in preclinical development at present.

It should be an interesting company to watch out for.

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