FDA Grants Priority Review to Keytruda for Third-Line Treatment of Small Cell Lung Cancer

Article

The Food and Drug Administration granted a priority review to Keytruda (pembrolizumab) for the third-line treatment of patients with advanced small cell lung cancer (SCLC).

The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) for the third-line treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy, according to Merck, the anti-PD-1 agent’s manufacturer.

“There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall,” Jonathan Cheng, M.D., vice president of oncology clinical research at Merck Research Laboratories, said in a press release. “Keytruda has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients.”

The supplemental biologic license application is based on data from the phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.

KEYNOTE-158 examined the efficacy of Keytruda in patients with metastatic or unresectable solid tumors — including SCLC. Meanwhile, KEYNOTE-028 assessed the safety and efficacy of the immunotherapy agent in patients with incurable, advanced, biomarker-positive solid tumors that have not responded to current therapy or for which current therapy is not appropriate

The agency is set to make a decision by June 17, 2019.

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For patients with cancer, the ongoing chemotherapy shortage may cause some anxiety as they wonder how they will receive their drugs. However, measuring drugs “down to the minutiae of the milligrams” helped patients receive the drugs they needed, said Alison Tray. Tray is an advanced oncology certified nurse practitioner and current vice president of ambulatory operations at Rutgers Cancer Institute in New Jersey. If patients are concerned about getting their cancer drugs, Tray noted that having “an open conversation” between patients and providers is key. “As a provider and a nurse myself, having that conversation, that reassurance and sharing the information is a two-way conversation,” she said. “So just knowing that we're taking care of you, we're going to make sure that you receive the care that you need is the key takeaway.” In June 2023, many patients were unable to receive certain chemotherapy drugs, such as carboplatin and cisplatin because of an ongoing shortage. By October 2023, experts saw an improvement, although the “ongoing crisis” remained. READ MORE: Patients With Lung Cancer Face Unmet Needs During Drug Shortages “We’re really proud of the work that we could do and achieve that through a critical drug shortage,” Tray said. “None of our patients missed a dose of chemotherapy and we were able to provide that for them.” Tray sat down with CURE® during the 49th Annual Oncology Nursing Society Annual Congress to discuss the ongoing chemo shortage and how patients and care teams approached these challenges. Transcript: Particularly at Hartford HealthCare, when we established this infrastructure, our goal was to make sure that every patient would get the treatment that they need and require, utilizing the data that we have from ASCO guidelines to ensure that we're getting the optimal high-quality standard of care in a timely fashion that we didn't have to delay therapies. So, we were able to do that by going down to the minutiae of the milligrams on hand, particularly when we had a lot of critical drug shortages. So it was really creating that process to really ensure that every patient would get the treatment that they needed. For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
Yuliya P.L Linhares, MD, an expert on CLL
Yuliya P.L Linhares, MD, and Josie Montegaard, MSN, AGPCNP-BC, experts on CLL
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