Carboplatin

Orphan designation: carboplatin Treatment of glioma, 19/02/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Patient, Committee, Carboplatin, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of glioma on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, OS, Pemetrexed, Chemotherapy, NSCLC, Progression-free survival, Patient, Carboplatin, Merck & Co., MRK, PARP, Cisplatin, PFS, Pharmaceutical industry

In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).

Key Points: 
  • In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed).
  • The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies.
  • “These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer.
  • We sincerely thank the patients and investigators for their important contributions to this study.”

Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2024

Retrieved on: 
Wednesday, March 6, 2024
Online, Carboplatin, CRDF, SAN, Cancer, Progression-free survival, PDX, Cetuximab, EGFR, Bev, Carcinoma, FOLFIRI, PLK1, AACR, Bevacizumab, RAS, Cisplatin, Ovarian cancer, Abstract, Paclitaxel, Patient, Clinical trial, Mutation, Publication, Vaccine

“In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.

Key Points: 
  • “In RAS-mutated mCRC, we are showing the underlying mechanism through which the combination of onvansertib and bevacizumab targets the hypoxia response pathway.
  • We believe this mechanism explains the strong clinical results we have seen in both our Phase 1b/2 and ONSEMBLE second-line RAS-mutated mCRC clinical trials.
  • The abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR.
  • Following presentation, the posters will be posted to the " Scientific Presentations " section of the Cardiff Oncology website.

G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Wednesday, February 28, 2024
G1 Therapeutics, Breast cancer, Carboplatin, Research, PIN, SCLC, Telephone, Update, J. P. Morgan, DMC, Food, Growth, SACT, G1, Trilaciclib, Hospital, ADC, OS, Conjugation, GAAP, Event, Therapy, Webcast, Patent, Patient, Acceleration, Clinical trial, Survival, Oncology, ITT, Pharmaceutical industry

G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.

Key Points: 
  • G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.
  • Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Tuesday, February 20, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, MSD, Carboplatin, MRK, Society of Gynecologic Oncology, Food, PDUFA, Risk, Cancer, Gynecologic Oncology (journal), Death, Paclitaxel, SGO, Patient, Pharmaceutical industry

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.
  • The sBLA is based on data from the Phase 3 NRG-GY018 trial.
  • Health authorities in Israel, Canada, Australia, Singapore and Brazil will review this application as part of Project Orbis.
  • In endometrial cancer, Merck is evaluating KEYTRUDA in the first-line setting for advanced or recurrent disease that is dMMR (KEYNOTE-C93/ENGOT-en15/GOG-3064) and in the adjuvant setting (KEYNOTE-B21/ENGOT-en11/GOG-3053).

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee

Retrieved on: 
Monday, February 12, 2024
G1 Therapeutics, Carboplatin, Breast cancer, Bone marrow, Data monitoring committee, DMC, OS, Safety, Therapy, TNBC, Patient, Survival, ITT, Rated R, Pharmaceutical industry

The DMC did not express any concerns regarding safety or recommend any other changes to the study.

Key Points: 
  • The DMC did not express any concerns regarding safety or recommend any other changes to the study.
  • G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.
  • PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC.
  • Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb).

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Fever, Fatigue, ATC, Vincristine, HGG, BRAF, EMA, Xeroderma, Carboplatin, International, Bleeding, Cough, Headache, Nausea, Neutropenia, Language, Neoplasm, Cancer, Mutation, Neutrophil, Radiation, Water, European Medicines Agency, Tablet, MEK, Growth, Select, Patient, Cell, LGG, Safety, Anatomy, Vomiting, IIA, Rash, Medical device

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 1, Status: Authorised