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This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.
The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy.
There are no currently approved therapies for desmoid tumors, but doctors often treat patients with chemotherapy, off-label targeted therapies, radiation, and surgery. The tumors do not spread to other parts of the body but can cause severe disability and pain in the tissues that they impact, like muscle or nerves.
The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy. The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial.
Epicur Pharma’s Advisory Council member Ann Donoghue, DVM, MS shares her personal perspective on the important relationship between veterinary oncology and compounded medications used in chemotherapy treatments. Many of the presentations discussed the chemotherapies available to treat dogs.
In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.
PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. The PSMAfore study. Novartis is evaluating opportunities to investigate Pluvicto in earlier stages of prostate cancer.
During treatment, patients would be given talazoparib would be used instead of chemotherapy, according to a statement by NICE. Weighing up the evidence NICE emphasised that data from a clinical trial revealed that talazoparib increased patient survival without the disease worsening, compared with chemotherapy.
The FDA approval is based on the data obtained from a global, multicentre, open-label Phase III TROPiCS-02 study conducted in 543 HR+/HER2- metastatic breast cancer patients who have received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease. Trodelvy showed 3.2 Trodelvy showed 3.2
In this episode, I’ll discuss the safety of early antibiotic discontinuation in hematology patients with fever of unknown origin during chemotherapy-induced neutropenia. Episode 741: Is it safe to use early antibiotic discontinuation in hematology patients with fever of unknown origin during chemotherapy-induced neutropenia?
Pluvicto is indicated for metastatic CRPC (mCRPC) patients previously treated with ADT and taxane chemotherapy. Wales concludes, “Novartis has recently filed for a label expansion, which would enable physicians to prescribe Pluvicto for patients with mCRPC not yet treated with taxane-based chemotherapies.
Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch off testosterone production helps men with castration-sensitive prostate cancer (CSPC).
The small molecule treatment is indicated as a first-line maintenance treatment for individuals with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy. ” The EC based its approval the Phase III ATHENA-MONO study results.
This kinase inhibitor is indicated to be used in combination with chemotherapy in adult patients with newly diagnosed Ph+ ALL. Based on the results from the PhALLCON study, an international randomised, open-label, multicentre Phase III clinical trial, the FDA granted the approval.
The Keytruda discussions were finely balanced, with some panellists suggesting that the drug’s use in previously-untreated UC could be limited to patients who aren’t able to tolerate any platinum-based chemotherapies. The post ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq appeared first on.
The approval from the FDA was based on the data obtained from the multiregional, open-label, single-arm POD1UM-201 trial, conducted in metastatic or recurrent locally-advanced MCC adults who did not receive systemic therapy previously for their advanced disease. Partial response was seen in 22 patients and complete response in 12 patients.
Treatment is generally with surgery, chemotherapy, or in some cases targeted therapy if a specific mutation in the tumour is identified. The new indication in IMTs isn’t expected to drive a big increase in sales as the condition is so rare – diagnosed in just 150 to 200 people in the US every year.
Clinical trials show that Trodelvy increases how long people have before their disease gets worse by three months, and extends survival by five months, compared with chemotherapy in this group of patients. “Both represent another step in delaying chemotherapy, allowing people to stay well for longer,” she added. .
The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults.
This review could potentially lead to the approval of the first combination treatment offering an alternative to platinum-containing chemotherapy as the first-line treatment for locally advanced or metastatic urothelial cancer (la/mUC) patients. Platinum-based chemotherapy is the existing standard of care for first-line la/mUC.
The approval of Advanced Accelerator Applications (AAA)’s Pluvicto is based on the alternate primary endpoint results from the randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one AR pathway inhibitor and one or two taxane regimens.
The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after surgery – and are at high risk of the disease coming back.
The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.
Despite initial treatment with Roche’s HER2-targeting antibody Herceptin (trastuzumab) and chemotherapy, patients with this type of breast cancer will often experience disease progression, according to AZ. More effective options are needed to further delay progression and extend survival, said the drugmaker.
The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).
Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to remove the tumour reduced the risk of recurrence, secondary cancers or death by 42% compared to placebo after 2.5 years of follow-up.
The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy). director of the FDA’s Center for Biologics Evaluation and Research.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Retsevmo (selpercatinib) as monotherapy for adults with advance RET fusion-positive non-small cell lung cancer requiring systemic therapy after previous immunotherapy and/or chemotherapy treatment.
In this episode, I’ll discuss the safety of early antibiotic discontinuation in hematology patients with fever of unknown origin during chemotherapy-induced neutropenia. Episode 741: Is it safe to use early antibiotic discontinuation in hematology patients with fever of unknown origin during chemotherapy-induced neutropenia?
Gilead’s Trodelvy (sacituzumab govetican), marketed for advanced breast and bladder cancer, is seeking a label expansion for first-line NSCLC in combination with Keytruda. GlobalData estimates the drug to earn $3.12 billion by 2029. “ Notably, the non-squamous patient subset had a median PFS of 5.6 months vs. 3.7 per cent versus 12.8
Repotrectinib has picked up three breakthrough designations from the FDA, including most recently for ROS1-positive metastatic NSCLC patients who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy.
AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already been treated with chemotherapy either before or after surgery and are at high risk of the disease coming back. Breast cancer is the most commonly diagnosed cancer worldwide with around 2.3
In the study, Enhertu was given to patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy.
Now, results from the ongoing TRANSFORM study show that Breyanzi was more effective than the standard second-line treatment – salvage therapy followed by high-dose chemotherapy and a stem cell transplant – at fending off disease recurrence.
The DESTINY-Breast06 trial is a global, randomised, open-label Phase III study that compares the efficacy and safety of ENHERTU with the investigator’s choice of chemotherapy in patients with HR positive, HER2 low or ultralow advanced or metastatic breast cancer.
This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.
KEYNOTE-826 enrolled 600 patients with both PD-L1-positive and PD-L1-negative tumours who were treated with a regimen of Keytruda and chemotherapy, given either with or without Roche’s Avastin (bevacizumab). The company hasn’t disclosed the data yet, but says it will do so at a future medical meeting.
The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.
Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug.
The study showed that adding Nubeqa to standard therapy with anti-androgen drugs and chemotherapy with docetaxel reduced the risk of dying by 32.5% The data will be filed with regulatory authorities to seek an expansion of the label for Nubeqa, according to Bayer, which developed Nubeqa in collaboration with Finland’s Orion.
About the Phase III trial for pancreatic ductal adenocarcinoma NAPOLI 3 is a randomised, open-label Phase III trial of Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma.
This asset is being assessed to treat patients with relapsed or refractory extensive-stage small-cell lung cancer (ES-SCLC) who have shown disease progression on or following treatment with platinum-based chemotherapy.
The 40-patient open-label study is the first to evaluate CAR-T therapy in treatment-naïve in high-risk LBCL, which is currently treated first-line mainly with rituximab and a chemo regimen known as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). billion.
AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.
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