Associated tags: HRR, Prostate cancer, BRCA, Patient, Cancer, Metastasis, Liver, Lung cancer, Pharmaceutical, Health, Oncology, Biotechnology, Clinical Trials, Pharmaceutical industry, FDA, Merck, NYSE, RPF, General Health, MSD, Death
Neutropenia,
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Pharmaceutical industry “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
Key Points:
- “We are delighted to showcase the latest encouraging clinical data from the FOR46-001 Phase 1 ADC trial,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen.
- In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression.
- The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts.
- These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with CD46 positive prostate cancer.
Oncology,
Health,
FDA,
General Health,
Clinical Trials,
Pharmaceutical,
Biotechnology,
European Commission,
Food,
HRR,
Risk,
Movement,
Prognosis,
PFE,
Confidence interval,
Disease,
Prostate cancer,
Doctor of Philosophy,
Civil service commission,
Cancer,
University,
PARP,
Death,
Clinical Cancer Research,
University of Glasgow,
ADP,
Talazoparib,
Patient,
Safety,
Medicine,
Inc.,
Pharmaceutical industry Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
Key Points:
- Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
- With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations.
- “The European Commission’s approval of talazoparib in combination with enzalutamide offers a meaningful advancement for the treatment of patients with metastatic castration-resistant prostate cancer, the most advanced and aggressive stage of the disease.”
“After years of fighting prostate cancer, it can be devastating for a patient to learn that their cancer has stopped responding to testosterone-lowering treatments.
- At this stage of the disease, the prognosis is generally poor,” said Erik Briers, MS, PhD, Vice Chairman, Europa UOMO, a European advocacy movement for people with prostate cancer.
MSD,
Patient,
CYP11A1,
Orion,
HRT,
Hormone replacement therapy,
Prostate cancer,
Orion Corporation,
Merck & Co.,
Research,
Corporation,
Merck,
OS,
Taxane,
Development,
Senior,
Pharmaceutical industry Orion Corporation (“Orion”) and MSD (known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada) have initiated two pivotal Phase 3 clinical trials evaluating ODM-208/MK5684, an investigational CYP11A1 inhibitor, in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
Key Points:
- Orion Corporation (“Orion”) and MSD (known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada) have initiated two pivotal Phase 3 clinical trials evaluating ODM-208/MK5684, an investigational CYP11A1 inhibitor, in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
- Patients are now enrolling in the trials, named OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650).
- The primary endpoints are overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.
- Secondary endpoints include time to first subsequent therapy (TFST), objective response rate (ORR) and duration of response (DOR).
Retrieved on:
Thursday, August 24, 2023
Biotechnology,
Health,
Pharmaceutical,
Clinical Trials,
Oncology,
MSD,
Prednisolone,
Department of Urology, University of Virginia,
HRR,
NHA,
NR,
CI,
Aes,
OS,
Cancer,
MRK,
Prognosis,
RPF,
AstraZeneca,
Merck & Co.,
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Death,
HIV disease progression rates,
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Risk,
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NYSE,
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Safety,
Fatigue,
Pharmaceutical industry,
EU,
Merck As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
Key Points:
- As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
- In the ITT population, common adverse events (AEs) in patients who received LYNPARZA plus abi/pred were anemia (45.5%), nausea (28.1%) and fatigue (27.9%).
- Despite various treatment options available, the prognosis for mCRPC remains poor, with limited treatment options for patients whose cancer progresses following initial treatment.
- This combination is also approved in the U.S. for the treatment of adult patients with deleterious or suspected deleterious BRCAm mCRPC.
DSM-IV codes,
Janssen Pharmaceuticals,
Neoplasm,
AE,
Prostate cancer,
Abiraterone acetate,
CI,
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HR,
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IA2,
Johnson & Johnson,
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Education,
Disease,
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Fatigue,
Pharmaceutical industry,
Medical imaging,
HORSHAM HORSHAM, Pa., Aug. 11, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.1
Key Points:
- *, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study.
- "All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes.
- This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes."
- "This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC."
Biotechnology,
General Health,
FDA,
Health,
Pharmaceutical,
MSD,
Prednisolone,
Disease,
Ars,
Diarrhea,
NHA,
NR,
Duke Cancer Institute,
The New England Journal of Medicine,
OS,
Cancer,
MRK,
RPF,
AstraZeneca,
Abdominal pain,
NEJM,
Merck & Co.,
Prednisone,
Dizziness,
SCM,
Lymphocytopenia,
Patient,
Anemia,
European,
Nausea,
BRCA,
ITT,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
NYSE,
AR,
Food,
Caregiver,
Fatigue,
Prostate cancer,
Pharmaceutical industry,
Medical imaging,
EU,
MD,
Propel,
Merck As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
Key Points:
- As previously reported, there was a statistically significant improvement in rPFS in the full intention-to-treat (ITT) population in the PROpel trial (n=796).
- Approximately 10% of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.
- LYNPARZA plus abi/pred is approved in several other countries for the treatment of appropriate adult patients with mCRPC based on the PROpel trial.
- For the U.S. indication, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Biotechnology,
General Health,
Health,
Pharmaceutical,
Oncology,
MSD,
Prednisolone,
Oncology Drug Advisory Committee,
The New England Journal of Medicine,
New Drug Application,
Cancer,
MRK,
ODAC,
AstraZeneca,
NEJM,
Merck & Co.,
Prednisone,
Incidence,
Surgical oncology,
Urology,
HIV disease progression rates,
Patient,
Physician,
Risk,
GenesisCare,
Propel,
Mortality,
BRCA,
FDA,
Death,
News,
NYSE,
Food,
Caregiver,
Prostate cancer,
Pharmaceutical industry,
Medical imaging,
Merck The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.
Key Points:
- The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.
- The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.
- The FDA is not bound by the committee’s guidance but takes its advice into consideration.
- AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.
BOCA RATON, Fla., March 02, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the year ended December 31, 2022 and provides a business update.
Key Points:
- BOCA RATON, Fla., March 02, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the year ended December 31, 2022 and provides a business update.
- Q4 2022 and 2022 Corporate Highlights:
Consolidating the Mild Cognitive Impairment (MCI) Phase 2 trial into the Mild Alzheimer’s Disease Phase 2 study which will become a single Phase 2 AD trial.
- Received research and development rebates from Australia and the United Kingdom in early 2023 that totaled approximately $6.4 million USD.
- As of December 31, 2022, the Company had cash and cash equivalents of approximately $52.2 million.
Biotechnology,
Pharmaceutical,
Men,
Oncology,
Health,
FDA,
Consumer,
Clinical Trials,
MSD,
NYSE,
Prednisolone,
Propel,
American Society of Clinical Oncology,
Oncology Drug Advisory Committee,
RPF,
Society,
Cancer,
Patient,
GU,
European,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
The New England Journal of Medicine,
ODAC,
MRK,
Food,
Prednisone,
ASCO,
Shanda,
AstraZeneca,
NEJM,
Pharmaceutical industry,
Merck The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.
Key Points:
- The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.
- The FDA is not bound by the committee’s guidance but takes its advice into consideration.
- AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
- LYNPARZA in combination with abi/pred is approved in the European Union and several other countries for the treatment of adult patients with mCRPC, based on the PROpel trial.
Retrieved on:
Tuesday, February 28, 2023
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Pharmaceutical industry,
Merck Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789.
Key Points:
- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789.
- Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment.
- In KEYNOTE-641, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm.
- We are extremely grateful to all the investigators and patients for their participation in these studies.”
