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

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 Pharmaceutical Companies Pharmaceutical Companies Labelling 104

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

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

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 FDA 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.

FDA 124

FDA Chemotherapy Labelling Immunization 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).

FDA 98

FDA 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

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

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

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 FDA 83

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

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

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

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.

FDA 105

FDA 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 FDA 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.

FDA 111

FDA Chemotherapy Labelling 111

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 FDA 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 FDA Labelling Immunization 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 FDA Labelling 64

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.

FDA 52

FDA Chemotherapy Labelling 52

Pharmaceutical Technology

OCTOBER 5, 2022

Additionally, chemotherapy regimens employed in treating CLL are known to deplete viable T-cell numbers, further exacerbating the lack of functional T-cells available to generate CAR-T cells. From a clinical perspective, CAR-T therapy may not be appropriate for patients who are typically eligible for cell therapies.

Chemotherapy 111

Chemotherapy Labelling 111

pharmaphorum

AUGUST 9, 2022

The data provide proof-of-principle for the use of MET-targeting drugs to offset Tagrisso resistance, and charts a way forward towards regulatory approvals of the combination as an alternative to chemotherapy for these patients. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Chemotherapy 52

Chemotherapy Labelling FDA 52

European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? There is great hope of this class of drug specifically to work in conjunction with immunotherapeutics, given the lack of toxicity of radiopharmaceuticals in general compared to most chemotherapies.

Chemotherapy 105

Chemotherapy Compounding Immunization FDA 105

pharmaphorum

JANUARY 23, 2023

The drug achieved an impressive 84% overall survival rate over 18 months in patients with advanced GEA who received it as a first-line therapy in combination with chemotherapy, according to data from the open-label study. The median progression-free survival (PFS) of 12.5 months, with a median duration of response was 20.4

Chemotherapy 52

Chemotherapy Labelling 52

pharmaphorum

JANUARY 10, 2022

The EU approval is based on the phase 2 CodeBreak 100 study in 733 subjects, which found that treatment with Lumykras was associated with a 37% objective response rate (ORR), defined as a 30% or greater reduction in tumour volume, when used as a second-line therapy for KRAS G12C-mutated NSCLC after chemotherapy and/or immunotherapy.

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. GlobalData analyst Dr Sakis Palioras said in a recent research not that Kimmtrak’s 5.7 ” Image by Pexels from Pixabay .

Labelling 52

Labelling Chemotherapy Immunization 52

The Checkup by Singlecare

MARCH 25, 2024

In human patients, it’s used to treat vomiting and nausea due to cancer chemotherapy or radiation therapy. Veterinarians commonly use ondansetron for chemotherapy, but its use in dogs is “ off-label.” Nausea-inducing chemotherapy is a common reason veterinarians give dogs ondansetron.

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Dosage Chemotherapy Compounding Pharmacies Compounding 52

pharmaphorum

APRIL 30, 2021

Merck’s drug has been approved for this use since 2017, but failed to show a statistically significant improvement over third-line chemotherapy in either of two confirmatory trials – KEYNOTE-061 and KEYNOTE-062.

Chemotherapy 59

Chemotherapy FDA Labelling 59

pharmaphorum

DECEMBER 5, 2022

Pluvicto becomes the first PSMA-targeted intravenous radioligand therapy – combining a targeting compound or ligand with a therapeutic radionuclide or radioactive particle (in this case, lutetium-177) – to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy.

Chemotherapy 59

Chemotherapy Compounding Labelling FDA 59

Hospital Pharmacy Europe

OCTOBER 19, 2023

Suitable for all women with advanced ovarian cancer, regardless of BRCA mutation status, who have responded to first-line platinum-based chemotherapy, rucaparib (brand name Rubraca) is a poly-ADP ribose polymerase (PARP) inhibitor. Dr Rebecca Kristeleit, consultant medical oncologist and adjunct reader at Guy’s and St.

Chemotherapy 52

Chemotherapy Labelling Hospitals 52