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II. New Indications

TOP - February 2019, Vol 12, No 1 - FDA Approvals, News & Updates

Adcetris First FDA-Approved Drug for CD30-Expressing Peripheral T-Cell Lymphomas

On November 16, 2018, the FDA approved brentuximab vedotin (Adcetris; Seattle Genetics), in combination with chemotherapy, for patients with untreated systemic ­anaplastic large-cell lymphoma (sALCL) or with other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angio­im­munoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA-approved drug for newly diagnosed PTCL, including sALCL. Brentuximab vedotin was previously approved by the FDA for classical Hodgkin lymphoma.

This new indication was based on a double-blind, multicenter clinical trial that randomized 226 patients to brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) and 226 patients to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). The efficacy was demonstrated by improvement in progression-free survival (PFS). The median PFS was 48.2 months (95% confidence interval [CI], 35.2-not estimable) in the brentuximab vedotin plus CHP arm versus 20.8 months (95% CI, 12.7-47.6) in the brentuximab vedotin plus CHOP arm (hazard ratio [HR], 0.71; 95% CI, 0.54-0.93; P = .011). Improvements with brentuximab vedotin plus chemotherapy were also seen in overall survival (HR, 0.66; 95% CI, 0.46-0.95; P = .024), complete response rates in the CHP and CHOP arms (68% vs 56%, respectively; P = .007), and overall response rates (83% vs 72%, respectively; P = .003).

The most common (≥20%) side effects that were more common in the brentuximab vedotin plus CHP arm were nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia. Peripheral neuropathy was reported in 52% of patients in the CHP arm and 55% in the CHOP arm. The FDA used its new Real-Time Oncology Review Pilot Program to approve this indication, which took <2 weeks to complete.

Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia

On November 21, 2018, the FDA accelerated the approval of venetoclax (Venclexta; AbbVie/Genentech), in combination with azacitidine (Vidaza), decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥75 years or those with comorbidities that preclude intensive induction chemotherapy.

The approval was based on 2 open-label, nonrandomized studies in patients with newly diagnosed AML aged >75 years or those who have comorbidities that preclude intensive induction chemotherapy. The efficacy was based on complete remission (CR) rates and duration.

In the first study of patients receiving venetoclax plus azacitidine, 25 (37%) patients achieved a CR (95% confidence interval [CI], 26-50), with a median remission of 5.5 months. In those receiving venetoclax plus decitabine, 7 (54%) patients achieved a CR (95% CI, 25-81), with a median remission of 4.7 months. In the second study, among 61 patients receiving venetoclax plus low-dose cytarabine, 13 (21%) patients achieved a CR (95% CI, 12-34), with a median remission of 6 months.

The most common (≥30%) side effects with venetoclax plus azacitidine, decitabine, or low-dose cytarabine were nausea, diarrhea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, peripheral edema, pneumonia, dyspnea, hemorrhage, anemia, rash, abdominal pain, sepsis, back pain, myalgia, dizziness, cough, oropharyngeal pain, pyrexia, and hypotension.

Ongoing phase 3 studies are evaluating venetoclax in combination with azacitidine or low-dose cytarabine, with overall survival as the primary end point.

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Last modified: June 4, 2019