Search Results for “cancer” – Page 34 – media

Seagen Touts Phase III Data for Breast Cancer Combo Therapy

By Connor Lynch Pictured: Cancer patient in bed looking out window/iStock, Ridofranz Biotech Seagen announced promising Phase III results Wednesday for its tyrosine kinase inhibitor Tukysa (tucatinib), in combination with Genentech’s antibody-drug conjugate Kadcyla (ado-trastuzumab emtansine), which met its primary endpoint of progression-free survival in HER-2 breast cancer patients. The HER2CLIMB-02 trial was investigating the efficacy of Tukysa in combination with Genentech’s Kadcyla to treat locally advanced or metastatic HER-2 breast cancer that had received previous treatment with taxane and trastuzumab. While the trial met the primary endpoint of PFS, the study’s data on its secondary endpoint of overall survival “were not yet mature,” Seagen Chief Medical Officer Roger Dansey said in a statement. The combination arm of the trial also resulted in more discontinuation “due to adverse events,” but also noted that “no new safety signals emerged for the combination.” Serious adverse reactions occurred in the study in 26% ...
- Source: drugdu
- 200
- August 18, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 112
- August 16, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 184
- August 16, 2023
Clinigen clears out cancer therapies in line with latest growth strategy

UK-headquartered Clinigen announced the divestment of global rights for four of its cancer therapies from its portfolio, as per a 10 August press release. The company gave away the rights of Cardioxane, Savene, Totect and Ethyol (amifostine), as Clinigen shifts its pharmaceutical strategy. The first three drugs use dexrazoxane to treat cardiotoxicity caused by cancer drugs while Ethyol is used to correct the effects of cancer treatment with cisplatin or radiation. Clinigen announced that the four drugs will join CNX Therapeutics’ pharmaceutical portfolio. Based in the UK, CNX Therapeutics commercialises and distributes pharmaceuticals in 40 countries globally. According to its website, the biotech is “seeking to expand its product portfolio in Europe and selected global markets.” This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics. This deal included an upfront payment of £166.7m ($211.8m), a milestone-based payment of £41.7m ($53m) upon first ...
- Source: drugdu
- 106
- August 15, 2023
Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 164
- August 15, 2023
Astellas invests $50m to support advancement of Poseida’s cancer cell therapy

Astellas Pharma and Poseida Therapeutics have announced a strategic investment to support Poseida’s commitment to redefining cancer cell therapy. Under the terms of the agreement, Astellas will invest a total of $50m, including $25m to acquire 8,333,333 in shares of the common stock of Poseida, as well as a one-time $25m payment for a right of exclusive negotiation and the first refusal to licence one of Poseida’s clinical stage programmes. In oncology, Poseida’s research and development of cell and gene therapies for cancer and rare genetic diseases provides a broad pipeline of allogeneic CAR-T cell therapy product candidates for solid and liquid tumours. This includes P-MUC1C-ALL01, an allogeneic CAR-T cell therapy that is currently in phase 1 development for multiple solid tumour indications. The company has provided Astellas with a board observer seat to allow it to attend scientific advisory board meetings, as well as certain notice rights related to ...
- Source: drugdu
- 111
- August 11, 2023
Eli Lilly announces positive results for Retevmo in phase 3 lung cancer study

Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
- Source: drugdu
- 197
- August 9, 2023
Study helps understand how RNA modification promotes pancreatic cancer

Chemical modifications of RNA molecules, such as m6A, can critically impact gene expression, influencing various aspects of cancer development and progression. However, while studies into m6A modification of messenger RNA (mRNA) have been extensive, exploration of its impact on lncRNAs, especially within the context of PDAC, has been relatively limited. In an innovative study published in the Genes & Diseases journal, a team from The Children’s Hospital, Zhejiang University School of Medicine, People’s Hospital of Hangzhou Medical College and University of Mississippi Medical Center employed a methylated RNA immunoprecipitation (MeRIP) strategy to uncover the role of LINC00901, an m6A-modified long noncoding RNA (lncRNA), in promoting the proliferation, survival, and invasiveness of pancreatic ductal adenocarcinoma (PDAC) cells, thus leading to tumor growth. Intriguingly, the study suggests that the m6A reader protein YTHDF1 negatively regulates LINC00901 expression. The team identified two m6A sites on LINC00901 essential for its interaction with YTHDF1. Their ...
- Source: drugdu
- 204
- August 8, 2023
With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
- Source: drugdu
- 130
- August 4, 2023
GSK’s Jemperli Beats Merck’s Keytruda for Frontline Endometrial Cancer Approval

By Tristan Manalac The FDA has approved GSK’s Jemperli (dostarlimab-gxly) for the treatment of primary advanced or recurrent endometrial cancer, the company announced Monday. The label expansion covers a combination regimen of Jemperli, carboplatin and paclitaxel, followed by Jemperli as a single agent. Monday’s approval also only applies to patients who are mismatch repair deficient (dMMR), as confirmed by an FDA-approved test, or who have high microsatellite instability (MSI-H). Jemperli is the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population, according to GSK. The expanded approval “redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer,” for whom chemotherapy alone has been the standard of care, though many patients still see disease progression, Hesham Abdullah, GSK’s senior vice president and global head of oncology development, said in a statement. Jemperli is an anti-PD-1 antibody that was first approved ...
- Source: drugdu
- 120
- August 3, 2023

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