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FDA NEWS: December 16, 2020 to January 14, 2021

TON - February 2021 Vol 14, No 1 - FDA Updates

This section provides a brief overview of new cancer drugs or new indications approved by the FDA between December 16, 2020, and January 14, 2021.


Xalkori Approved for Pediatric Patients and Young Adults with Relapsed or Refractory ALK-Positive ALCL

On January 14, 2021, the FDA approved crizotinib (Xalkori; Pfizer) for the treatment of pediatric patients aged ≥1 years and young adults with relapsed or refractory systemic ALK-positive anaplastic large-cell lymphoma (ALCL). The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory systemic ALK-positive ALCL.

The approval of crizotinib was based on the results of a multicenter, single-arm, open-label clinical trial of 121 patients aged 1 to ≤21 years that included 26 patients with relapsed or refractory systemic ALK-positive ALCL after ≥1 systemic treatments.

Patients received crizotinib dosed at 280 mg/m2 (N = 20) or 165 mg/m2 (N = 6) orally twice daily until disease progression or unacceptable toxicity. Patients could discontinue crizotinib to undergo hematopoietic stem-cell transplantation.

The objective response rate (ORR) in the 26 patients was 88%, with a complete remission rate of 81%. Of the 23 patients who achieved a response, 39% maintained their response for ≥6 months and 22% maintained their response for ≥12 months.

The most common (≥35%) adverse reactions, excluding laboratory abnormalities, were diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. The most common (≥15%) grade 3/4 laboratory abnormalities were neutropenia (62%), lymphopenia (35%), and thrombocytopenia (19%).

The FDA previously granted crizotinib a priority review for this indication.

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Orgovyx First Oral Hormone Therapy Approved for Advanced Prostate Cancer

On December 18, 2020, the FDA approved the oral gonadotropin-releasing hormone receptor antagonist relugolix (Orgovyx; Myovant Sciences) for the treatment of adult patients with advanced prostate cancer. As a gonadotropin-releasing hormone receptor antagonist, relugolix reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

The approval of relugolix for this indication was based, in part, on the results of a phase 3 randomized trial

of men with advanced prostate cancer. Patients in this trial were randomized to relugolix once daily or injections of the hormone-targeting drug leuprolide every 3 months for 48 weeks.

The objective of the study was to determine whether relugolix achieved and maintained low enough levels of testosterone (castrate levels) by day 29 through the end of the course of

treatment. Among the 622 patients in the relugolix arm, the castration rate was 96.7%.

The most common (≥10%) adverse reactions reported among relugolix-treated patients included hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

The FDA previously granted relugolix a priority review for this indication.

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FDA Approves Margenza for Metastatic HER2-Positive Breast Cancer

On December 16, 2020, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adult patients with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received ≥2 previous anti-HER2 regimens, at least 1 of which was for metastatic disease.

The approval was based, in part, on results of a phase 3 randomized, multicenter, open-label trial of 536 patients with HER2-positive metastatic breast cancer who had received previous treatment with other anti-HER2 therapies. Patients were randomized in a 1:1 ratio to margetuximab or trastuzumab in combination with 1 of 4 chemotherapy agents: capecitabine, eribulin, gemcitabine, or vinorelbine.

The primary efficacy end points included progression-free survival (PFS) and overall survival. Median PFS in the margetuximab and control arms were 5.8 months versus 4.9 months, respectively. Additional efficacy end points included ORR and duration of response.

Results showed a statistically significant 24% reduction in the risk for disease progression or death with margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio, 0.76; 95% confidence interval, 0.59-0.98; P =.033; median PFS 5.8 vs 4.9 months). The ORR was 22% for margetuximab plus chemotherapy and 16% for trastuzumab plus chemotherapy. Overall survival data are expected in the second half of 2021.

The most common (>10%) adverse reactions reported among margetuximab-treated patients included fatigue/asthenia (57%), nausea (33%), diarrhea (25%), and vomiting (21%). Infusion-related reactions occurred in 13% of patients receiving margetuximab, with the majority reported as grade ≤2.

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Last modified: February 17, 2021