Seattle Genetics Lymphoma Drug Gets Second Green Light from FDA Panel

Seattle Genetics batted a clean 2-for-2 today in its appearances in front of an FDA advisory committee.

The FDA’s Oncologic Drugs Advisory Committee voted 10-0 to recommend that Seattle Genetics’ brentuximab vedotin (Adcetris), be cleared for sale as a new treatment in the U.S. for anaplastic large cell lymphoma. That decisive vote came after a morning session in which the panel voted 10-0 in favor of the same drug for a related malignancy, Hodgkin’s lymphoma.

Both of these conditions are quite rare. About 8,500 patients in the U.S. get Hodgkin’s each year, and while about two-thirds get cured by standard chemotherapy, about one-third relapse. About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months, according to Barbara Pro, a researcher at Fox Chase Cancer Center in Philadelphia, who studied the Seattle Genetics drug in clinical trials.

The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions, with no sign of their tumors anywhere on imaging scans. The complete remissions lasted for a median time of 13.2 months, before the tumors began to re-appear, Seattle Genetics said. The main side effect was peripheral neuropathy, a form of nerve damage in which patients feel numbness and tingling in their fingers and toes.

“This drug is wildly active in this rare population. The toxicity is concern, but not a dealbreaker for patients without other options,” said Mikkael Sekeres, an oncologist at the Cleveland Clinic, in explaining his vote at the afternoon hearing.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new therapy will be Seattle Genetics’ first marketed product after 14 years in business, and it would be in position to be the first commercially successful version of an “empowered antibody” that specifically zeroes in on tumors, mostly spares healthy tissues, and unleashes a potent toxin against tumors.

Trading in Seattle Genetics stock (NASDAQ: SGEN) was halted today during the FDA panel’s deliberations, and is expected to resume tomorrow.

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  • Despite the 10-0 positive votes from the FDA advisory panel, analyst David Miller of Biotech Stock Research warned in a note to clients this afternoon that Seattle Genetics stock could drop 20-30 percent when trading starts back up. That’s because Richard Pazdur, the head of the FDA’s cancer drug unit, insisted during the public hearing that an ongoing trial known as Aethera isn’t properly designed to confirm the results of other trials. Pazdur, in his concluding remarks, said that unless the FDA and the company can agree to a new plan for trials that confirm the results, then “we’ll bring it back to ODAC,” meaning the FDA would delay the application and hold another hearing.

    Seattle Genetics said it plans to hold a webcast conference call with investors at 8:30 am ET/5:30 am PT tomorrow.

  • It’s good to see the FDA effect policy in a timely benefice manner. But lets bare in mind that this isn’t a common occurrence, especially in diseases that afflict smaller proportions of the American population whose medications, despite the smaller number of patients, require equal testing, driving up the costs. Because of the rarity of such medications the costs are already high and less frequently covered by insurance.

    Even in situations that pertained to significant percentage of Americans, like sunscreen regulation to stem the rise of melanoma patients which was growing a 3-7% annually, kills at a rate of one person an hour and costs taxpayers $2,000,000,000 a year took 33 years.

    So before we applaud the FDA for the good their regulations will bring, let’s not forget the FDA’s system is fundamentally flawed. The FDA’s credo is “Promoting and Protecting Your Health,” and it’s about time they owned up to that by providing swifter, and more efficient solutions that aren’t dependent on over-regulating.

    The FDA got it right this time. Only time will tell if this become a consistent practice.

  • Ryan Willis

    So when (approx) is this drug expected to be accessible to the general public to those who need it? I’m not talking about through a clinical trial, but just available for everybody.