April 16, 2019 – FDA Approvals, News & Updates

Another Approval for Keytruda and An Easing of Pregnancy Restrictions for Women Taking Soltamox
Web Exclusives - FDA Approvals, In the News
Yvette Florio Lane

In This Article


FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%)

On April 11, 2019, the US Food and Drug Administration (FDA) approved Keytruda (pembrolizumab; Merck Inc) for the first-line treatment of patients with metastatic non–small- cell lung cancer (NSCLC) or stage III unresectable NSCLC or for patients who are not candidates for definitive chemoradiation. Patients’ tumors must have no EGFR or ALK mutations and express PD-L1 Tumor Proportion Score (TPS) ≥1%.

This approval was based on KEYNOTE 042, a multicenter, open-label, active-controlled trial conducted in 1274 randomized (1:1) 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. Randomization was stratified by ECOG performance status, histology, geographic region, and PD-L1 expression (TPS ≥50% vs TPS 1%-49%). Patients received either pembrolizumab 200 mg intravenously every 3 weeks or a carboplatin chemotherapy regimen with either pemetrexed or paclitaxel.

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

The most common adverse reactions reported in at least 10% of patients who received pembrolizumab as a single agent in this study included fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia, and weight loss.

Previously, pembrolizumab has been approved for use in the treatment of patients with metastatic NSCLC whose tumors express PD-L1 TPS ≥50%. Other indications for pembrolizumab include the treatment of melanoma, Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, head and neck cancer, and Merkel-cell carcinoma.

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FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox

On April 8, the FDA reduced the amount of time from 9 months to 2 months that a woman taking tamoxifen must use nonhormonal contraception or otherwise avoid pregnancy following the last dose. This is the second time in fewer than 2 years that the FDA has changed the recommended post-Soltamox (tamoxifen citrate, oral solution) contraception period after the cessation of the breast cancer treatment.

The new labeling recommends women avoid pregnancy for a period of only 2 months. This is a return to its original recommendation; prior to September 25, 2018, the FDA recommended that women avoid pregnancy for 2 months following the cessation of tamoxifen. On September 25, 2018, the FDA extended the advised contraception or avoidance of pregnancy period from 2 months to 9 months. This move was made to bring it in line with the advice in the draft it had issued in 2017, “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry,” and not on any new clinical data about 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.

This is not a final decision. In the event that any adverse events or maternal or fetal abnormalities are reported, the FDA will likely reverse it.

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Last modified: April 30, 2019
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