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FDA NEWS December 2020

TON - December 2020, Vol 13, No 6 - FDA Updates

This section provides a brief overview of new cancer drugs or new indications approved by the FDA between September 1, 2020, and October 14, 2020.

FDA Extends Approval of Keytruda for Classical Hodgkin Lymphoma

On October 14, 2020, the FDA extended the approval of pembrolizumab (Keytruda; Merck Sharp & Dohme Corp.), a PD-1–blocking antibody, for adult patients with relapsed or refractory classical Hodgkin lymphoma and pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma that has relapsed after 2 or more lines of therapy.

The FDA granted pembrolizumab an orphan drug designation, breakthrough therapy designation, and priority review for this indication.

Approval was based on the results of the KEYNOTE-204 study, a phase 3, randomized, open-label clinical trial in 304 adult patients with relapsed or refractory classical Hodgkin lymphoma after receiving treatment with at least 1 multiagent regimen. Patients were randomized in a 1:1 ratio to receive either pembrolizumab 200 mg every 3 weeks or brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 2 years.

The efficacy of pembrolizumab in adults and pediatric patients with relapsed or refractory classical Hodgkin lymphoma was based on progression-free survival (PFS) per blinded independent central review assessment. The PFS was statistically significantly longer in the pembrolizumab arm. The median PFS was 13.2 months (95% CI, 10.9-19.4) in the pembrolizumab arm and 8.3 months (95% CI, 5.7-8.8) in the brentuximab vedotin arm.

Serious adverse reactions occurred in 30% of the patients who received pembrolizumab. Serious adverse reactions that occurred in ≥1% of patients were pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Adverse reactions that occurred in ≥20% of the patients who received pembrolizumab included upper respiratory tract infection, musculoskeletal pain, diarrhea, cough, pyrexia, fatigue, and rash. Adverse reactions requiring treatment with systemic corticosteroids occurred in 38% of patients, including pneumonitis, which occurred in 11% of patients.

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FDA Approves Opdivo and Yervoy for Unresectable Malignant Pleural Mesothelioma

On October 2, 2020, the FDA approved the combination of nivolumab (Opdivo; Bristol Myers Squibb), a PD-1–blocking antibody, and ipilimumab (Yervoy; Bristol Myers Squibb), a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody, for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

The FDA approved the combination of nivolumab and ipilimumab based on the results of a prespecified interim analysis of the Checkmate-743 study, a phase 3, randomized, open-label clinical trial in patients with unresectable malignant pleural mesothelioma who had received no previous anticancer therapy.

The study demonstrated a statistically significant improvement in OS for patients treated with nivolumab plus ipilimumab for 2 years (N = 303) compared with those who received combination chemotherapy with cisplatin or carboplatin plus pemetrexed (Alimta; N = 302). The median OS was 18.1 months and 14.1 months, respectively (hazard ratio [HR], 0.74; 95% CI, 0.61-0.89; P = .002). These results were observed after a minimum of 22 months of follow-up. At 2 years, 41% of the patients who received nivolumab plus ipilimumab were alive compared with 27% of those who received chemotherapy.

“The survival results from the CheckMate-743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard-of-care option. This is exciting news, instilling hope for patients with this devastating disease and for the healthcare providers who care for them,” said study investigator Anne S. Tsao, MD, Professor and Section Chief, Thoracic Medical Oncology, and Director of the Mesothelioma Program, The University of Texas M.D. Anderson Cancer Center, Houston, in the press release.

Nivolumab plus ipilimumab is a unique combination of 2 immune checkpoint inhibitors that features a potentially synergistic mechanism of action, targeting 2 different checkpoints (PD-1 and CTLA-4). Ipilimu­mab augments T-cell activation and proliferation, while nivolumab helps existing T-cells in tumor surveillance. Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.

The most common (≥20%) adverse reactions in the patients who received the combination of nivolumab plus ipilimumab were fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritus.

For the treatment of unresectable malignant pleural mesothelioma, the recommended dose of nivolumab is 360 mg every 3 weeks and the recommended dose of ipilimumab is 1 mg/kg every 6 weeks, until disease progression or unacceptable toxicity or for up to 2 years in patients without disease progression.

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Onureg Approved for Acute Myeloid Leukemia

On September 1, 2020, the FDA approved azacitidine (Onureg; Celgene Corporation), an oral nucleoside metabolic inhibitor, for the continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after intensive induction chemotherapy and who are not able to complete intensive curative therapy.

The FDA approved azacitidine based on the results of the QUAZAR study, a multicenter, randomized, double-blind, clinical trial of 472 patients with acute myeloid leukemia who achieved CR or CRi with intensive induction chemotherapy with or without subsequent consolidation therapy.

Patients were randomized in a 1:1 ratio to receive azacitidine 300 mg (N = 238) or placebo (N = 234) orally on days 1 to 14 of each 28-day cycle.

The main efficacy outcome measure was overall survival (OS). The median OS was 24.7 months (95% confidence interval [CI], 18.7-30.5) in the azacitidine arm compared with 14.8 months (95% CI, 11.7-17.6) in the placebo arm. A subgroup analysis showed consistency in the OS benefit with azacitidine between patients who had CR and those who had CRi.

The most common (≥10%) adverse reactions in patients receiving azacitidine were nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in an extremity.

The recommended dose is 300 mg orally once daily with or without food on days 1 to 14 of each 28-day cycle. Treatment with azacitidine should be continued until disease progression or unacceptable toxicity.

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Last modified: December 28, 2020