Pharmacy Times

SEPTEMBER 16, 2024

Data from the second interim analysis of the DETECT V trial, presented at ESMO Congress 2024, suggest that a chemotherapy-free regimen combining dual HER2-targeted therapy with endocrine therapy, particularly with the addition of ribociclib, may be an effective treatment for patients.

Chemotherapy 52

Chemotherapy 52

European Pharmaceutical Review

JUNE 27, 2024

Immunotherapy in oncology “The addition of pembrolizumab to chemotherapy represents a new frontline therapeutic option for patients with primary advanced or recurrent endometrial carcinoma” Moreover, last week saw US regulatory approval of a combination treatment for endometrial cancer : KEYTRUDA (pembrolizumab) plus chemotherapy.

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Chemotherapy 64

The Guardian - Pharmaceutical Industry

NOVEMBER 5, 2023

Exclusive: Regulator extends part suspension of licence to July 2024 after IT blunder led to incorrect dosage of cancer treatment A private health company paid millions by the NHS has failed to fix safety defects that led to the death of a cancer patient, the Guardian can reveal.

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Dosage Chemotherapy 94

Pharmaceutical Technology

DECEMBER 11, 2024

The prevailing treatment paradigm for newly diagnosed multiple myeloma (NDMM) patients who have received autologous stem cell transplantation (SCT) primarily consists of chemotherapy or Johnson & Johnsons (J&J) Darzalex in combination with chemotherapy.

Chemotherapy 59

Chemotherapy 59

European Pharmaceutical Review

SEPTEMBER 12, 2023

A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. percent with chemotherapy. months for chemotherapy. The overall survival rate at one year with Tedopi was 44.4 percent versus 27.5

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Vaccines Chemotherapy Immunization Immunity 98

Pharmacy Times

MARCH 14, 2025

Tarlatamab was approved by the FDA in May 2024 for patients who progressed after platinum-based chemotherapy.

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Chemotherapy 47

Pharmacy Times

DECEMBER 11, 2024

Assessing pre-treatment TIL levels in young breast cancer patients could help predict response to neoadjuvant chemotherapy.

Immunity 52

Immunity Immunization Chemotherapy 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

The humanised IgG4 anti-PD-1 antibody is indicated for unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. The FDA’s target action date is the second half of 2024. months for chemotherapy. months for TEVIMBRA versus 6.3

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Chemotherapy Immunization Immunity 105

Big Molecule Watch

JANUARY 10, 2025

Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone.

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Biosimilars Drug Pricing Labelling Communication 45

pharmaphorum

SEPTEMBER 6, 2022

The company’s lead drug PTX-061 is intended to improve the effectiveness of chemotherapy in patients with AML , which at the moment is only effective in around 20% of patients. The company said it will develop the new drug very quickly, and is eyeing regulatory filings with the FDA and EMA “as early as 2024.”

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Chemotherapy Immunity Immunization 103

European Pharmaceutical Review

MAY 20, 2024

This includes antibody production, chemotherapy drug and linker synthesis, conjugating the drug-linker to the antibody, as well as filling of the completed ADC substance, AstraZeneca confirmed. The pharmaceutical firm stated that it is planning to begin the design and construction of the manufacturing facility by the end of 2024.

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Chemotherapy 98

European Pharmaceutical Review

OCTOBER 25, 2024

The biologic ZL-1310 is being investigated in an ongoing Phase Ia/Ib study in these patients who have had at least one platinum-based chemotherapy regimen. This initial data on ZL-1310 was presented this week at the EORTC-NCI-AACR (ENA) Symposium 2024.

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Chemotherapy Compounding Immunity Immunization 97

Pharmaceutical Technology

SEPTEMBER 6, 2022

Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. . It also boosts the drug’s safety, tolerability and efficacy.

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Chemotherapy Drug Development 98

Pharmaceutical Business Review

APRIL 25, 2024

GSK has received the US Food and Drug Administration’s (FDA) acceptance for its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) along with standard-of-care chemotherapy (carboplatin and paclitaxel). It was conducted in two parts.

Chemotherapy 59

Chemotherapy 59

European Pharmaceutical Review

JUNE 5, 2024

The updated analysis for the biologic Jemperli were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract LBA3512). Hesham Abdullah , Senior Vice President, Global Head Oncology, R&D, GSK noted that the data showing “no evidence of disease in 42 patients is remarkable”.

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Chemotherapy 98

PharmExec

DECEMBER 5, 2023

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Chemotherapy 52

Chemotherapy 52

European Pharmaceutical Review

FEBRUARY 21, 2024

TAGRISSO as a combination treatment with chemotherapy was recently approved in the US, based on data from the FLAURA2 Phase III trial. Results from a Phase III trial in the neoadjuvant setting are expected later in 2024. According to AstraZeneca, the small molecule treatment TAGRISSO is also being investigated in two Phase III trials.

Chemotherapy 105

Chemotherapy 105

pharmaphorum

AUGUST 31, 2022

In May, a Phase 2 study started, comparing Kaiku’s electronic patient-reported outcome (ePRO) approach to evaluating immune-related adverse events to the standard model of care in cancer patients treated with checkpoint inhibitor drugs, with results due towards the end of 2023 or in early 2024.

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Chemotherapy Immunity Immunization Hospitals 116

Big Molecule Watch

FEBRUARY 6, 2025

Chinas National Medical Products Administration (NMPA) previously accepted the new drug application (NDA) for HLX11 on December 4, 2024. The BLA for HLX11 is supported by data from a series of studies for HLX11 versus PERJETA, including analytical similarity studies and two comparative clinical studies.

Biosimilars 59

Biosimilars Chemotherapy 59

Pharmaceutical Business Review

AUGUST 19, 2024

The application for ENHERTU is supported by data from the DESTINY-Breast06 Phase III trial, which was highlighted at the 2024 American Society of Clinical Oncology Annual Meeting. These patients had not received prior chemotherapy for advanced disease and had undergone at least two lines of endocrine therapy in the metastatic setting.

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

MARCH 25, 2022

facility at Kent Science Park (KSP) in Sittingbourne is due to open in 2024, and when fully operational will create more than 100 new highly skilled jobs. If trials are successful, nabiximols could become one of the first additions to treatment for glioblastoma patients since temozolomide chemotherapy in 2007. The 60,000 sq.

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Chemotherapy Pharmaceutical Manufacturing 98

Pharmaceutical Business Review

OCTOBER 23, 2024

The transaction is expected to be finalised in the fourth quarter of 2024, subject to standard closing conditions. It is used in combination with chemotherapy for adult patients with metastatic HER2-positive breast cancer who have previously undergone two or more anti-HER2 regimens.

Chemotherapy 52

Chemotherapy 52

Express Pharma

MAY 6, 2024

This antibody-directed killing of cancer has the potential to substantially increase the outcomes of current cancer therapies, such as chemotherapy. One of its drugs, Rina-S, is a potential best-in-class ADC that was granted Fast Track designation by the FDA in early 2024 for the treatment of ovarian cancer. billion in 2023.

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Chemotherapy 93

Express Pharma

JUNE 13, 2024

CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, chemotherapy remains the mainstay of treatment across the first and second line for advanced pancreatic cancer.

Chemotherapy 105

Chemotherapy 105

pharmaphorum

SEPTEMBER 16, 2021

The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.

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Chemotherapy Vaccines 105

Big Molecule Watch

FEBRUARY 7, 2025

CuraTeQ Biologics DYRUPEG , a biosimilar referencing NEULASTA (pegfilgrastim), is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Biosimilars 59

Biosimilars Chemotherapy Diabetes 59

European Pharmaceutical Review

JANUARY 10, 2024

Patients who have undergone surgery for pancreatic cancer are still at risk for relapse of the disease, even after they finish chemotherapy. A Phase II trial will commence later in 2024, utilising a new formulation of the ELI-002 cancer vaccine, targeting additional KRAS mutations. This is compared to 4.01

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Vaccines Chemotherapy 98

Pharmacy Times

SEPTEMBER 16, 2024

Abstracts from the OrigAMI-1 and MARIPOSA-2 trials indicated the treatment benefits of amivantamab-vmjw and chemotherapy in multiple cancer indications.

Chemotherapy 20

Chemotherapy 20

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

Pharmaceutical Business Review

JULY 5, 2024

The medication is indicated for use in various patient groups, including those with newly diagnosed Acute Myeloid Leukemia (AML) who are over 75 years old or have other health conditions that prevent them from undergoing intensive chemotherapy.

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Dosage Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

OCTOBER 4, 2020

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

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Immunity Immunization Chemotherapy 98

Big Molecule Watch

OCTOBER 31, 2023

LOQTORZI is expected to be available in the United States in Q1 2024. The active ingredient in LOQTOZI, toripalimab, is a monoclonal antibody that binds programmed death receptor-1 (PD-1) and blocks its interactions with ligands PD-L1 and PD-L2 with high potency, enabling the immune system to activate and kill the tumor.

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Chemotherapy Immunization Immunity 49

Pharmaceutical Business Review

APRIL 8, 2024

As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion.” Submissions for New Drug Applications (NDAs) in the US and EU are expected in 2024. The post US FDA grants breakthrough status to Dizal’s sunvozertinib appeared first on Pharmaceutical Business review.

Chemotherapy 59

Chemotherapy 59

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. GEA is the fifth most common cancer worldwide, and around one in five patients have tumours that are HER2-positive.

Chemotherapy 52

Chemotherapy Labelling 52

Big Molecule Watch

DECEMBER 16, 2024

IMFINZI was approved for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted after securingPriority Reviewand Breakthrough Therapy Designation for this indication in August 2024.

Chemotherapy 45

Chemotherapy 45

pharmaphorum

SEPTEMBER 2, 2021

The PANTHER trial looked at the combination of pevonedistat in combination with azacitidine chemotherapy as first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and low-blast acute myeloid leukaemia (AML).

Chemotherapy 52

Chemotherapy 52

Big Molecule Watch

SEPTEMBER 29, 2023

FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 20, 2024, for the application. The post FDA Grants Priority Review to Merck’s Application for KEYTRUDA (pembrolizumab) as Part of Treatment for Early-Stage Cervical Cancer appeared first on Big Molecule Watch.

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Chemotherapy 45