April 16, 2019 – FDA Approvals, News & Updates

FDA Approvals, News & Updates, In the News


In This Article


Keytruda Receives Expanded Indication for First-Line Treatment of Non–Small-Cell Lung Cancer

On April 11, 2019, the US Food and Drug Administration (FDA) expanded the indication for pembrolizumab (Keytruda; Merck) to include the first-line treatment of patients with stage III unresectable non–small-cell lung cancer (NSCLC) who are not candidates for definitive chemoradiation, as well as those with metastatic NSCLC. Patients’ tumors cannot have EGFR or ALK mutations and must express PD-L1, defined as a tumor proportion score (TPS) ≥1%.

Previously, single-agent pembrolizumab was indicated in the first-line setting for the treatment of patients with metastatic NSCLC (TPS ≥50%) whose tumors do not harbor EGFR or ALK abnormalities.

This latest approval was based on the multicenter, open-label, active-controlled KEYNOTE 042 clinical trial of 1274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumors expressed PD-L1 (TPS ≥1%) as determined by an FDA-approved immunohistochemistry assay. Patients were randomized in a 1:1 ratio to intravenous pembrolizumab 200 mg every 3 weeks or a carboplatin-based chemotherapy regimen with either pemetrexed or paclitaxel. Randomization was stratified by ECOG performance status, histology, geographic region, and PD-L1 expression (TPS ≥50% vs TPS 1%-49%).

Major efficacy measures were overall survival (OS) in the TPS ≥50% NSCLC subgroup, the TPS ≥20% NSCLC subgroup, and the overall population (TPS ≥1%); OS was significantly improved for patients in the pembrolizumab arm compared with the chemotherapy arms in all 3 of these subgroups. There were no significant differences in progression-free survival or overall response rate between arms in any subgroup.

The most common (≥10%) adverse reactions with single-agent pembrolizumab included fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.

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FDA Changes Recommended Contraception Period Following Soltamox Therapy

On April 8, 2019, the FDA reduced the amount of time (from 9 months to 2 months) that women must use nonhormonal contraception or otherwise avoid pregnancy following their last dose of tamoxifen (Soltamox; Midatech Pharma US).

This is the second time in fewer than 2 years that the FDA has changed the recommended post-Soltamox contraception period after cessation of the breast cancer treatment.

The updated label suggests that women avoid pregnancy for a period of only 2 months, which is a return to the FDA’s original recommendation. On September 25, 2018, the FDA extended the advised contraception or avoidance of pregnancy period from 2 months to 9 months. This was done to align with guidance found in the draft “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry,” and was not based on new clinical data regarding tamoxifen.

The FDA has now re-evaluated the postmarket reports and published literature and has found no drug-associated maternal or fetal abnormalities or adverse events in women who became pregnant 2 to 9 months after cessation of the drug and has returned to its original recommendation. The new labeling advises that tamoxifen can cause fetal harm and advises women of reproductive potential to use effective nonhormonal contraception during treatment and for 2 months following the last dose.

In the event that any adverse events or maternal or fetal abnormalities are reported, the FDA will likely reverse the decision.

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