STAT

NOVEMBER 27, 2023

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.

Chemotherapy 85

Chemotherapy FDA Labelling 85

European Pharmaceutical Review

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. Benefits of daily oral chemotherapy over IV.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

Hospital Pharmacy Europe

AUGUST 2, 2023

This global, multi-centre, open-label, Phase 3 study, evaluated Trodelvy versus the physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine or vinorelbine). as assessed by blinded independent central review for participants treated with Trodelvy compared to those treated with chemotherapy.

Chemotherapy 86

Chemotherapy Labelling Hospitals 86

European Pharmaceutical Review

NOVEMBER 22, 2023

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.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

JULY 15, 2022

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.

FDA 116

FDA Chemotherapy Labelling 116

Pharmaceutical Technology

MARCH 23, 2023

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.

FDA 98

FDA Adverse Reactions Compounding Chemotherapy 98

pharmaphorum

APRIL 29, 2021

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.

Labelling 52

Labelling FDA Chemotherapy 52

pharmaphorum

OCTOBER 25, 2021

The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. months to 23 months, according to data reported at this year’s ESMO cancer conference.

Chemotherapy 87

Chemotherapy FDA Labelling 87

Pharmaceutical Technology

NOVEMBER 25, 2022

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.

Adverse Reactions 105

Adverse Reactions Chemotherapy Labelling 105

pharmaphorum

DECEMBER 3, 2021

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).

Chemotherapy 94

Chemotherapy Labelling 94

European Pharmaceutical Review

AUGUST 17, 2022

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.

Chemotherapy 122

Chemotherapy Compounding Labelling 122

pharmaphorum

NOVEMBER 3, 2021

HER2-positive gastric cancer is generally treated first with chemotherapy plus Roche’s Herceptin (trastuzumab) or a biosimilar in Europe, but treatment options are few if the disease progresses, according to Daiichi Sankyo’s head of oncology R&D Gilles Gallant. billion licensing deal.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

SEPTEMBER 7, 2022

The European Commission has approved Tecartus (brexucabtagene autoleucel) for adults aged 26 and over with relapsed or refractory B-cell precursor ALL, a patient population not covered by the label for Novartis’ CD19 CAR-T Kymriah (tisagenlecleucel), which covers paediatric and young adult patients up to age 25.

Labelling 98

Labelling Chemotherapy Hospitals 98

pharmaphorum

JULY 14, 2022

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. .

Chemotherapy 96

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Labelling 96

pharmaphorum

SEPTEMBER 26, 2022

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.

Chemotherapy 97

Chemotherapy Labelling FDA 97

pharmaphorum

AUGUST 4, 2021

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).

FDA 98

FDA Chemotherapy Labelling 98

pharmaphorum

JUNE 4, 2021

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.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

OCTOBER 4, 2021

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.

FDA 78

FDA Chemotherapy Labelling 78

STAT

OCTOBER 28, 2024

This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility , STAT explains. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.

Labelling 66

Labelling Chemotherapy 66

pharmaphorum

MARCH 12, 2021

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.

Chemotherapy 111

Chemotherapy Labelling 111

pharmaphorum

MARCH 13, 2022

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.

FDA 129

FDA Chemotherapy Labelling 129

The Checkup by Singlecare

NOVEMBER 21, 2024

Adults and children weighing more than 40 kg (88 lbs) Adults, children, and infants 1 month and older Conditions treated by famotidine and pantoprazole Famotidine is FDA-approved to treat stomach ulcers and duodenal ulcers, while pantoprazole is often prescribed off-label for both ulcerative conditions. pylori) in the stomach.

Labelling 98

Labelling Insurance FDA Chemotherapy 98

pharmaphorum

JUNE 6, 2022

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.

Chemotherapy 98

Chemotherapy FDA Labelling 98

pharmaphorum

NOVEMBER 30, 2021

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

FDA 110

FDA Chemotherapy Labelling 110

pharmaphorum

FEBRUARY 21, 2022

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.

Chemotherapy 132

Chemotherapy Labelling 132

pharmaphorum

OCTOBER 4, 2022

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.

Chemotherapy 52

Chemotherapy Labelling FDA 52

pharmaphorum

FEBRUARY 18, 2022

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.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

MARCH 10, 2022

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.

Labelling 81

Labelling Chemotherapy 81

Pharmaceutical Technology

NOVEMBER 13, 2022

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.

FDA 52

FDA Chemotherapy Labelling Immunization 52

European Pharmaceutical Review

JANUARY 23, 2023

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.

Chemotherapy 104

Chemotherapy Labelling FDA 104

European Pharmaceutical Review

AUGUST 10, 2022

The prospective, open-label, single-arm, Phase II TUXEDO-1 study enrolled 14 women and one man with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy. .”

Chemotherapy 98

Chemotherapy Labelling Hospitals 98

pharmaphorum

DECEMBER 14, 2021

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.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

MARCH 8, 2021

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.

Chemotherapy 98

Chemotherapy Labelling FDA 98

pharmaphorum

SEPTEMBER 25, 2020

Furthermore, the duration of response with the PD-1 checkpoint inhibitor was nearly five times longer at 29 months versus just over six months with frontline chemotherapy. of the chemo group.

Chemotherapy 75

Chemotherapy Labelling Patient Care FDA 75

Pharmaceutical Technology

NOVEMBER 23, 2022

Libtayo is also indicated for treating progression of the disease on or following platinum-based chemotherapy. Based on the open-label, multicentre, international Phase III EMPOWER-Cervical 1 clinical trial findings, the regulatory agency granted approval in advanced cervical cancer.

Adverse Reactions 52

Adverse Reactions Chemotherapy Immunization Labelling 52

pharmaphorum

NOVEMBER 23, 2022

Regeneron has announced that the European Commission (EC) has approved Libtayo (cemiplimab) as a monotherapy for the treatment of adult patients with second-line recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. The results were published in the New England Journal of Medicine.

Chemotherapy 59

Chemotherapy Labelling Immunization Vaccines 59

pharmaphorum

NOVEMBER 26, 2020

Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies. And combination trials with chemotherapy are also planned. Two single-centre studies in previously-untreated neuroblastoma patients are already underway, with preliminary data from one available and the other due shortly.

FDA 102

FDA Chemotherapy Labelling 102