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.

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Hospital Pharmacy Europe

SEPTEMBER 7, 2023

The use of adjunctive alectinib reduced disease recurrence in the early setting for people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) compared to platinum-based chemotherapy, its manufacturer Roche has announced. The OS data were immature at the time of the interim analysis.

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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).

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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.

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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.

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pharmaphorum

AUGUST 8, 2022

Around 60% of that HER2-negative group can now be considered as HER2-low – roughly 140,000 cases using a back-of-the-envelope calculation – who can now consider Enhertu treatment as an alternative to endocrine therapy or chemotherapy.

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FDA Chemotherapy Labelling 52

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

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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.

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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.

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Chemotherapy FDA Labelling 87

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.

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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.

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FDA Chemotherapy Labelling 78

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.

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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. .

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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

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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.

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Labelling Chemotherapy 52

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).

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Chemotherapy Labelling 96

pharmaphorum

SEPTEMBER 21, 2021

The accelerated approval for Tivdak (tisotumab vedotin) is for women whose cancer has progressed on or after first-line chemotherapy, according to the pharma company and its partner Genmab. There’s no word yet on a price for Tivdak, which will launch with a black box warning for ocular toxicity on its label.

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FDA Chemotherapy Labelling 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.

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FDA Chemotherapy Labelling 116

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.

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FDA Chemotherapy Labelling 52

Hospital Pharmacy Europe

NOVEMBER 23, 2023

Some 217 patients with R/R follicular lymphoma who had received at least two prior lines of systemic therapy were included in the global, randomised, open-label study. Brukinsa is a chemotherapy-free, oral treatment option that can be a practice-changing option for eligible patients with relapsed or refractory follicular lymphoma.’

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Labelling Chemotherapy Hospitals 52

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.

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Pharmaceutical Technology

JUNE 7, 2023

Known as Pedmark in the US, Pedmarqsi is the first and only therapy to receive approval in the European Union to prevent cisplatin chemotherapy-induced hearing loss (ototoxicity) in patients aged between one month and 18 years with localised, non-metastatic solid tumours.

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Chemotherapy Labelling 52

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.

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Chemotherapy Labelling 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.

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Chemotherapy FDA Labelling 98

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.

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Chemotherapy FDA Labelling 64

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 .

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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).

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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.

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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.

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Labelling Chemotherapy 81

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.

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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.

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pharmaphorum

MARCH 24, 2022

In the VISION study reported at ASCO last year, Pluvicto given on top of standard care reduced the risk of death by 38% compared to standard care alone in men with PSMA+ mCRPC who had progressed after three or more prior anti-androgen and chemotherapy regimens. After a median follow-up of 20.9 months, compared to 3.4 months, respectively.

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Chemotherapy Labelling FDA 59

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.

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Chemotherapy Labelling 59

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.

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pharmaphorum

NOVEMBER 17, 2021

The decision makes Inrebic an alternative to chemotherapy, radiation therapy, splenectomy or red blood cell transfusions in myelofibrosis patients who no longer respond to Jakavi treatment.

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Labelling Chemotherapy 52

pharmaphorum

NOVEMBER 14, 2022

The narrower label for Zejula (niraparib) means it can only be used as second-line maintenance therapy after platinum-based chemotherapy in patients with these cancers whose tumours carry a germline BRCA mutation – around 15% of the population. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

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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

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