KEYTRUDA

KEYTRUDA | AstraZeneca Intelligence | Humanexa

Regulatory Timeline

FDA, EMA, PMDA, and other regulatory milestones from linked signals and precedents.

FDAJun 16, 2026safety_guidance
FDA AP — KEYTRUDA (SUPPL)
Application BLA125514. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PEMBROLIZUMAB.
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FDAJun 16, 2026safety_guidance
FDA AP — KEYTRUDA QLEX (SUPPL)
Application BLA761467. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PEMBROLIZUMAB, BERAHYALURONIDASE ALFA-PMPH.
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FDAJun 16, 2026safety_guidance
FDA AP — INQOVI (SUPPL)
Application NDA212576. Sponsor: TAIHO ONCOLOGY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CEDAZURIDINE, DECITABINE.
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MerckJun 16, 2026mid-term
Merck's Sacituzumab Tirumotecan Shows OS and PFS Improvement in Endometrial Cancer Phase 3 Trial
As the first ADC to show significant improvement in OS and PFS for this indication, regulatory submissions will be critical to ensure timely market entry and compliance with health authorities.
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FDAJun 16, 2026safety_guidance
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
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LillyJun 16, 2026mid-term
Lilly's Retevmo shows 83% reduction in disease recurrence for early-stage RET fusion-positive lung cancer
The trial results may influence treatment guidelines and regulatory discussions around RET fusion testing, impacting future approvals and labeling.
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MerckJun 16, 2026mid-term
5-Year Data Shows Intismeran Autogene + KEYTRUDA Reduces Melanoma Recurrence Risk by 49%
The promising trial results may facilitate expedited regulatory review processes for the combination therapy, impacting approval timelines and market entry.
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FDAJun 16, 2026safety_guidance
FDA AP — KEYTRUDA (SUPPL)
Application BLA125514. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PEMBROLIZUMAB.
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FDAJun 16, 2026safety_guidance
FDA AP — KEYTRUDA QLEX (SUPPL)
Application BLA761467. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PEMBROLIZUMAB, BERAHYALURONIDASE ALFA-PMPH.
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FDAJun 16, 2026safety_guidance
FDA AP — INQOVI (SUPPL)
Application NDA212576. Sponsor: TAIHO ONCOLOGY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CEDAZURIDINE, DECITABINE.
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FDAJun 16, 2026safety_guidance
FDA AP — INQOVI (SUPPL)
Application NDA212576. Sponsor: TAIHO ONCOLOGY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CEDAZURIDINE, DECITABINE.
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FDAJun 16, 2026approval
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
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Evidence Sources

Source-backed references used to construct this page.

FDA AP — INQOVI (SUPPL)
FDA
FDA document
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FDA AP — INQOVI (SUPPL)
FDA
FDA document
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Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA
FDA document
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Sunscreen: How to Help Protect Your Skin from the Sun
FDA
FDA document
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Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
FDA
FDA document
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Evaluation of Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer
ClinicalTrials.gov
FDA document
View source
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)
ClinicalTrials.gov
FDA document
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KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-
ClinicalTrials.gov
FDA document
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Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
ClinicalTrials.gov
FDA document
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Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov
FDA document
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Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
ClinicalTrials.gov
FDA document
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Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov
FDA document
View source
Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
Merck
FDA document
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Reshaping immunotherapy sequencing strategy: equivalent survival with induction plus consolidation vs. consolidation-only strategy in unresectable stage III NSCLC.
PubMed
FDA document
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An automatic detection model for spread through air spaces in postoperative pathological sections based on deep learning in NSCLC.
PubMed
FDA document
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CXCL13-expressing CD4(+) T cells coordinate the lymphocytes triad to promote the anti-tumor immunity in NSCLC.
PubMed
FDA document
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Inhibition of STAT3-mediated glycolysis by bruceine D suppresses non-small-cell lung cancer progression in vitro and in vivo.
PubMed
FDA document
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Trial watch: antibody-drug conjugates in cancer therapy.
PubMed
FDA document
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5-Year Data Shows Intismeran Autogene + KEYTRUDA Reduces Melanoma Recurrence Risk by 49%
Merck
FDA document
View source
Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA®
Merck
FDA document
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KEYTRUDA

Asset Overview

Company Context

Regulatory Timeline

FDA AP — KEYTRUDA (SUPPL)

FDA AP — KEYTRUDA QLEX (SUPPL)

FDA AP — INQOVI (SUPPL)

Merck's Sacituzumab Tirumotecan Shows OS and PFS Improvement in Endometrial Cancer Phase 3 Trial

Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death

Lilly's Retevmo shows 83% reduction in disease recurrence for early-stage RET fusion-positive lung cancer

5-Year Data Shows Intismeran Autogene + KEYTRUDA Reduces Melanoma Recurrence Risk by 49%

FDA AP — KEYTRUDA (SUPPL)

FDA AP — KEYTRUDA QLEX (SUPPL)

FDA AP — INQOVI (SUPPL)

FDA AP — INQOVI (SUPPL)

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

Related Signals

Evidence Sources