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Roche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
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Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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ADC oncology therapy market to value over $36b by 2029
With antibody-drug conjugates (ADCs) gaining favour as oncology treatments, research shows Daiichi Sankyo, Seagen and Roche are currently three of the market's most important players.
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Astellas to advance oncology CAR-T therapy
An investment of $50 million by Astellas Pharma in Poseida Therapeutics’ Phase I allogeneic CAR-T product candidate for solid tumour indications is set to advance the cancer immunotherapy field.
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Will ESR1-mutated breast cancer treatment gain approval?
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
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Roche agrees to develop oncology small molecule inhibitor
An agreement to obtain a global license for KSQ Therapeutics’ small molecule USP1 inhibitor, which has potential to treat a variety of cancers, has been signed by Roche.
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Post-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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Bispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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Could faecal transplants improve melanoma immunotherapy?
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
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BioNTech to support trial access for cancer immunotherapies
Signing of a major agreement between BioNTech SE and the UK government for cancer trials means more patients could access personalised immunotherapies.
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FDA approves off-the-shelf bispecific antibody cancer therapy
The US Food and Drug Administration (FDA) has approved the first bispecific antibody with a fixed-duration treatment in (R/R) diffuse large B-cell lymphoma (DLBCL).
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World’s largest lutetium-177 production site opens
The new German facility has Industry 4.0 capabilities and will produce radionuclides to help meet the rising demand for radiopharmaceuticals.
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Small molecule treatment reduces risk of death by half in NSCLC
Astrazeneca’s small molecule tyrosine kinase inhibitor reduced the risk of death by 51 percent in non-small cell lung cancer (NSCLC), a major Phase III study has shown.
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Nivolumab plus chemo provides one-year PFS in 94 percent lymphoma patients
A PD-1 checkpoint inhibitor plus chemotherapy is expected to become new standard of care for advanced Hodgkin lymphoma, based on Phase III trial data.
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CHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
