From Comments by Edward A. Faber, Jr., DO, MS, a medical oncologist and hematologist with OHC who specializes in blood cancers and stem cell transplants. Source: U.S. Food and Drug Administration

December 10, 2018

The U.S. Food and Drug Administration has expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the FDA used a new review program to complete the approval more quickly.

The new Real-Time Oncology Review (RTOR) program allows the FDA to review key data before the official application is submitted. This allows the FDA team to start reviewing findings earlier, so when the complete application is submitted, they are already familiar with the data. This sets the path for a more efficient, timely and thorough review. RTOR allowed the FDA to approve this indication within two weeks of the completed application’s submission.

“As new cancer treatments are being approved at accelerated rates, it is important for physicians to pursue the mechanisms to provide these new treatments in a timely fashion, especially with more aggressive cancers like PTCLs,” said Edward A. Faber, Jr., DO, MS, a medical oncologist and hematologist with OHC who specializes in blood cancers and bone marrow stem cell transplants. “As always, our patients’ safety is of the utmost importance, but we also understand that our patients are people with normal daily lives: they have spouses, children, co-workers and friends. It is our responsibility to remain up-to-date, and translate these new treatments to surround our patients with the latest treatments in order to survive this disease.”

Peripheral T-cell lymphomas are rare, fast-growing non-Hodgkin lymphomas that develop from white blood cells called T-cells. The T-cells often spread quickly throughout the body and are hard to treat.

Adcetris was previously approved by the FDA to treat adults with the following:

  • Previously untreated stage III or IV classical Hodgkin lymphoma
  • Classical Hodgkin lymphoma after relapse
  • Classical Hodgkin lymphoma after stem cell transplant when a patient is at a high risk of relapse or progression
  • Systemic ALCL after failure of other treatment
  • Primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment

Adcetris is now approved to treat previously untreated systemic anaplastic large cell lymphoma and other CD30-expressing peripheral T-cell lymphomas in combination with chemotherapy.

The new approval was based on a clinical trial of 452 patients who received either Adcetris plus chemotherapy or a standard chemotherapy as first-line treatment. The amount of time a patient stays alive without the cancer growing was significantly longer in the Adcetris group (48 months compared to 21 months). Overall survival and overall response rates were also significantly better in the Adcetris arm.

The most common side effects of Adcetris plus chemotherapy included nerve damage, nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever and low red blood cell count.

The FDA granted this application Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Adcetris to Seattle Genetics.

For more than 30 years, OHC has been providing patients access to the latest treatments combined with unmatched personal and emotional support to surround patients with everything they need to fight cancer. For more information about treatments for blood cancers including peripheral T-cell lymphomas, contact OHC at 1-800-710-4674.

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