Truqap

Truqap | Novartis Intelligence | Humanexa

Regulatory Timeline

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

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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FDAJun 16, 2026safety_guidance
FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
Why this matters: sets a safety guidance precedent in the same sub-indication (breast cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
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FDAJun 16, 2026safety_guidance
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Why this matters: sets a safety guidance precedent in the same sub-indication (breast cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
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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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AstraZenecaJun 16, 2026near-term
Camizestrant Recommended for 1st-Line ER-Positive Breast Cancer in EU
The recommendation from the CHMP indicates a strong likelihood of approval, which could lead to rapid market entry and necessitate compliance with new treatment protocols.
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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.
View detail
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.
View detail
AstraZenecaJun 16, 2026near-term
Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer
The approval of Datroway sets a precedent for TROP2-directed therapies, which may influence future regulatory pathways and approvals for similar agents in oncology.
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FDAJun 16, 2026approval
FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
Why this matters: sets a approval precedent in the same sub-indication (prostate cancer) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
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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.
View detail
AstraZenecaJun 16, 2026near-term
FDA ODAC Recommends Truqap for PTEN-Deficient Prostate Cancer
The recommendation from the FDA ODAC is a critical step towards final approval, which could enhance AstraZeneca's positioning in the oncology market and set a precedent for future targeted therapies.
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AstraZenecaJun 16, 2026near-term
Truqap approved in US for PTEN-deficient metastatic prostate cancer
The approval signifies a successful regulatory pathway for a novel treatment, which may encourage further investment and development in targeted therapies for prostate cancer, influencing future regulatory strategies.
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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
View source
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA
FDA document
View source
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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Sunscreen: How to Help Protect Your Skin from the Sun
FDA
FDA document
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Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy
ClinicalTrials.gov
FDA document
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Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer
ClinicalTrials.gov
FDA document
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Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer
ClinicalTrials.gov
FDA document
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Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
ClinicalTrials.gov
FDA document
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Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
ClinicalTrials.gov
FDA document
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MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
ClinicalTrials.gov
FDA document
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Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
ClinicalTrials.gov
FDA document
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Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
ClinicalTrials.gov
FDA document
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Diagnostic and prognostic value of lncSPATA8-AS1 in prostate cancer and its regulatory effect on tumor progression.
PubMed
FDA document
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Ubiquitination-anchored signature defines neuroendocrine prostate cancer: hub genes and single-cell ecosystem insights from integrated bioinformatics analysis of public transcriptomic datasets.
PubMed
FDA document
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Gut microbial metabolism of Flutamide attenuates its therapeutic efficacy against prostate cancer.
PubMed
FDA document
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Normalized periprostatic adipose tissue thickness: an imaging marker associated with prostate biopsy outcomes among patients with PI-RADS and PSA double gray zone.
PubMed
FDA document
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Trial watch: antibody-drug conjugates in cancer therapy.
PubMed
FDA document
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Polyploid giant cancer cells: the hidden players in ovarian cancer progression and prognosis.
PubMed
FDA document
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TGFA promotes the development of cervical cancer via interacting with DSG2.
PubMed
FDA document
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Truqap

Asset Overview

Company Context

Regulatory Timeline

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers

FDA AP — INQOVI (SUPPL)

Camizestrant Recommended for 1st-Line ER-Positive Breast Cancer in EU

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

FDA ODAC Recommends Truqap for PTEN-Deficient Prostate Cancer

Truqap approved in US for PTEN-deficient metastatic prostate cancer

Related Signals

Competitive Intelligence

Evidence Sources