Search Results for “cancer” – Page 30 – media

Roche announces positive phase 3 results for Alecensa in early-stage lung cancer

Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By reducing the risk of recurrence or ...
- Source: https://www.pmlive.com/pharma_news/roches_alecensa_shows_promise_in_phase_3_early-stage_lung_cancer_trial_1502267
- 120
- October 30, 2023
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
- Source: drugdu
- 103
- October 20, 2023
Air pollution linked to increased breast cancer risk in women

Women living and working in places with higher levels of fine particle air pollution are more likely to get breast cancer than those living and working in less polluted areas. Results of the first study to take account of the effects of both residential and workplace exposure to air pollution on breast cancer risk are presented at the ESMO Congress 2023 in Madrid, Spain. Professor Béatrice Fervers, Head of Prevention Cancer Environment Department, Léon Bérard Comprehensive Cancer Centre, France, said, “Our data showed a statistically significant association between long term exposure to fine particle air pollution, at home and at work, and risk of breast cancer. This contrasts with previous research which looked only at fine particle exposure where women were living, and showed small or no effects on breast cancer risk.” In the study, home and workplace exposure to pollution in 2419 women with breast cancer was compared to ...
- Source: drugdu
- 194
- October 19, 2023
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
- Source: drugdu
- 170
- October 19, 2023
Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients. The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases. Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases. “BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval. The study, which is evaluating the combination ...
- Source: drugdu
- 117
- October 17, 2023
FDA Clears Pfizer’s Braftovi + Mektovi for Non-Small Cell Lung Cancer Treatment

Treatment indicated for patients with BRAF V600E-mutant metastatic form of disease. Image Credit: Adobe Stock Images/Tex vector Pfizer revealed that the FDA has approved Braftoni (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Previously, the medication was approved for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, chief oncology research and development officer, EVP, Pfizer. “Since its initial FDA approval in 2018, Braftovi + Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant ...
- Source: drugdu
- 106
- October 17, 2023
report

Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
- Source: drugdu
- 177
- October 14, 2023
Merck’s Keytruda hits overall survival goal in early lung cancer as FDA decision nears

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
- Source: drugdu
- 118
- October 12, 2023
Merck shares positive results for Keytruda in phase 3 bladder cancer study

Merck & Co – known as MSD outside the US and Canada – has shared positive results from a late-stage trial of its anti-PD-1 therapy Keytruda (pembrolizumab) in certain bladder cancer patients. The phase 3 AMBASSADOR trial has been evaluating Keytruda versus observation as an adjuvant treatment for patients with localised muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma. At a pre-specified interim analysis, Keytruda demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of disease-free survival versus observation in these patients after surgery. The safety profile of Keytruda was consistent with that observed in previously reported studies, Merck said, adding that the National Cancer Institute-sponsored study will continue to evaluate its second dual primary endpoint of overall survival. More than 82,000 people in the US are expected to be diagnosed with bladder cancer this year, and approximately 7% of bladder cancer cases are locally advanced ...
- Source: drugdu
- 134
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 196
- October 10, 2023

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