Express Pharma

SEPTEMBER 18, 2024

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.

Chemotherapy 105

Chemotherapy Labelling Pharmaceutical Companies Pharmaceutical Companies 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 107

Chemotherapy Labelling 107

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

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 Chemotherapy 52

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.

Chemotherapy 116

Chemotherapy Labelling 116

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 104

Chemotherapy Labelling Pharmaceutical Companies Pharmaceutical Companies 104

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

Pharmaceutical Business Review

FEBRUARY 16, 2024

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.

Chemotherapy 64

Chemotherapy Labelling 64

Pharmaceutical Business Review

MARCH 20, 2024

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.

Chemotherapy 59

Chemotherapy Labelling 59

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

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 98

Chemotherapy Labelling 98

pharmaphorum

JANUARY 26, 2022

“Every year in the US, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options,” said Immunocore chief executive Bahija Jallal.

Chemotherapy 124

Chemotherapy Labelling Immunization Immunity 124

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).

Chemotherapy 98

Chemotherapy Labelling 98

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

Express Pharma

FEBRUARY 21, 2024

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

Chemotherapy 111

Chemotherapy Labelling Immunization Immunity 111

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 Labelling 98

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

JUNE 11, 2021

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.

Chemotherapy 83

Chemotherapy Labelling 83

Pharmaceutical Business Review

AUGUST 19, 2024

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.

Chemotherapy 59

Chemotherapy Labelling 59

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 52

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.

Chemotherapy 52

Chemotherapy Labelling Immunization Immunity 52

Pharmaceutical Business Review

AUGUST 21, 2024

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.

Chemotherapy 64

Chemotherapy Labelling 64

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 98

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

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.

Chemotherapy 105

Chemotherapy Labelling 105

pharmaphorum

AUGUST 4, 2022

The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-hormonal therapy.

Chemotherapy 105

Chemotherapy Labelling 105

pharmaphorum

FEBRUARY 8, 2021

Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment.

Chemotherapy 111

Chemotherapy Labelling 111

Express Pharma

AUGUST 2, 2024

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and paediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Chemotherapy 52

Chemotherapy Labelling 52

pharmaphorum

DECEMBER 13, 2021

The AGILE trial, which compared the combination of Tibsovo (ivosidenib) and Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) to Vidaza plus placebo as a first-line therapy for IDH1-positive AML, showed a three-fold improvement in overall survival. billion takeover of Agios Pharma’s oncology business last year.

Labelling 52

Labelling Chemotherapy 52

pharmaphorum

DECEMBER 13, 2021

“The current standard of care consisting of chemotherapy and transplant is not effective at curing most patients with high risk relapsed large B-cell lymphoma, representing a huge unmet need in our field,” commented Manali Kamdar of the University of Colorado Cancer Centre, a TRANSFORM investigator.

Chemotherapy 98

Chemotherapy Labelling 98

Pharmaceutical Technology

MARCH 6, 2023

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

Chemotherapy 52

Chemotherapy Labelling Immunization Immunity 52

Pharmaceutical Business Review

SEPTEMBER 23, 2024

This global, open-label, randomised, controlled study enrolled 453 patients to assess the efficacy and safety of mirvetuximab soravtansine versus investigator’s choice of single-agent chemotherapy in patients with platinum-resistant, high-grade serous ovarian cancer expressing high levels of FRα.

Chemotherapy 59

Chemotherapy Labelling 59

Pharmaceutical Business Review

NOVEMBER 6, 2023

Krazati has been approved as a monotherapy to treat adult patients with advanced NSCLC with KRAS G12C mutation and who have progressive disease after previous therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

MAY 26, 2022

The US regulator has approved Tibsovo (ivosidenib) in combination with Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) as a first-line therapy for IDH1-mutated acute myeloid leukaemia (AML), expanding the eligible patient population for the drug.

Chemotherapy 52

Chemotherapy Labelling 52

pharmaphorum

AUGUST 31, 2022

The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

Chemotherapy 64

Chemotherapy Labelling 64

Pharmaceutical Business Review

MAY 6, 2024

The BLA seeks approval for the use of subcutaneous nivolumab as a monotherapy, as maintenance therapy after treatment with Opdivo plus Yervoy (ipilimumab) combination regimen, or along with chemotherapy or cabozantinib in adult patients.

Chemotherapy 59

Chemotherapy Labelling 59