FDA gives Merck green light for new indication for Keytruda
Merck has received the Food and Drug Administration’s permission for Keytruda as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters [cm]), II, or IIIA non-small cell lung cancer.
“While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer. Unfortunately, many of these patients who undergo surgery still see their disease return,” said Roy Herbst, deputy director and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital and ensign professor of medicine (medical oncology) and professor of pharmacology, Yale School of Medicine. “Today’s approval for Keytruda offers a new, important immunotherapy treatment option for stage IB (T2a ≥4 cm), II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy. This provides, for the first time, an adjuvant immunotherapy treatment option for non-small cell lung cancer patients with stage IB disease and regardless of PD-L1 expression.”
[Read more: FDA gives green light for Keytruda plus Lenvima combination]
“Six years ago, Keytruda was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. Today’s approval marks the fifth indication for KEYTRUDA in non-small cell lung cancer and the first indication for Keytruda in patients with resected stage IB (T2a ≥4 cm), II, or IIIA disease following adjuvant chemotherapy,” said Gregory Lubiniecki, vice president, oncology global clinical development, Merck Research Laboratories. “This is an important milestone as we continue our efforts to pursue meaningful advances for patients with non-small cell lung cancer.”
With this approval, Keytruda is the only immunotherapy with an approved option for NSCLC regardless of PD-L1 expression in both the adjuvant and metastatic settings.
[Read more: Merck given FDA approval for new Vaxneuvance indication]
In addition to today’s approval in the adjuvant setting, Keytruda is indicated in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; in combination with carboplatin and either paclitaxel or paclitaxel protein-bound for the first-line treatment of patients with metastatic squamous NSCLC; as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic; and as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.