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WASHINGTON — A nonprofit formed by hospitals to deal with drug shortages is considering a move into chemotherapies. Frustrated by drug shortages and the price spikes that typically ensue, executives from large hospital systems launched the nonprofit Civica Rx to deal with the problem in September 2018.
Results presented from the Phase III IMpower133 study and extension trial IMbrella A, show Roche’s Tecentriq (atezolizumab), in combination with chemotherapy, demonstrates a potential long-term overall survival (OS) benefit as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). 0.91; p=0.0069). 0.91; p=0.0069).
. “As published in The Lancet, in a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, Libtayo reduced the risk of death by 43% compared to chemotherapy. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy.
Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy. Between 2018 and 2021, 30 children in nine countries were treated with blinatumomab. The treatment was added to the existing chemotherapy, Interfant-06.
Through the Cancer Drugs Fund (CDF), in 2018, England was the first European country to provide access to a CAR T-cell therapy to treat these blood cancers. Since then, over 500 patients in England have received axi-cel. CAR T-cell therapy engineers a patient’s own immune cells (T-cells) to detect, target and destroy cancer cells.
The co-founder of Los Angeles biotech Enochian Biosciences has been arrested in connection with a federal investigation into the murder of a Vermont man in 2018. The Department of Justice said that Banks is suspected of kidnapping Gregory Davis from his Danville home on 6 January, 2018 and carrying out his murder.
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).
The Nijmegen, Netherlands-based biotech was founded in 2018 to develop therapies designed to change the balance of protein expression within the tumour ‘microenvironment’, which can defend cancers against the immune system, and is increasingly becoming a source of new targets in oncology. The Series A round includes €3.6
According to the press release, FYLNETRA—Amneal’s third biosimilar launch in the United States since late last year—is used to treat neutropenia (low neutrophils, a type of white blood cell that fights infection) which is commonly experienced by patients undergoing chemotherapy.
Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ).
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.
The PROpel study included 796 mCRPC patients who had not received prior chemotherapy or NHAs in the mCRPC setting. Trials peaked at 115 in 2018 before declining to 91 last year. Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. So far, 68 trials have been initiated in 2023.
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.
Yescarta is administered to the patient via a single intravenous infusion following the administration of a round of chemotherapy designed to accommodate the new cells and minimise the patient’s immune reaction to them. About 50% will ultimately relapse post-transplant. Since then, over 500 patients in England have received axi-cel.
On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively. The post FDA looks at pulling speedy approvals for three cancer drugs appeared first on.
The strategy to build in cancer dates back to 2015, and has since gathered momentum with the purchase of the oncology businesses of Shire and Agios Pharma in 2018 and 2020, for $2.4 billion and $1.8 billion respectively, as well as smaller deals such as its takeover of Danish antibody specialist Symphogen.
New data from the VISION study showed that 177Lu-PSMA-617 on top of standard care reduced the risk of death by 38% compared to standard care alone in men with PSMA-positive metastatic castration-resistant prostate cancer (CRPC) who had progressed after three or more anti-androgen and prior chemotherapy regimens.
NICE has issued 17 positive pieces of guidance for breast cancer since 2018. Evidence shows that administering the drug with chemotherapy before surgery and continuing with pembrolizumab after surgery, improves the chance the cancer will be prevented. Pembrolizumab plus chemotherapy success in previous clinical trials.
Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug. The post In a class first, Merck’s Keytruda extends survival in cervical cancer appeared first on.
AstraZeneca’s hopes of developing its PD-L1 inhibitor Imfinzi for cervical cancer have been hit by a failed phase 3 trial of the drug alongside chemotherapy as a first-line treatment for women with locally-advanced tumours.
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) has been cleared for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor inhibitors and taxane-based chemotherapy or not medically suitable for taxane drugs. After a median follow-up of 20.9
The CRPC trial – KEYNOTE-921 – looked at the combination of Keytruda (pembrolizumab) with docetaxel in more than 1,000 patients who had not been treated with chemotherapy before, but who had seen disease progression despite earlier treatment with an anti-hormonal therapy.
That data has now been review, and NICE has upgraded Tecentriq (atezolizumab) to full NHS access for patients with advanced UC who have not received treatment before but cannot have cisplatin-based chemotherapy, and whose tumours have a PD-L1 expression of 5% or more.
The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy?
” J&J paid Argenx a hefty $300 million upfront to secure rights to cusatuzumab (also known as JNJ-4550) in December 2018, and also made a $200 million equity investment in the Belgian company as part of a deal that had a total value of $1.6
Ipsen and Servier’s hopes of extending the uses for chemotherapy drug Onivyde have been knocked back by a failed phase 3 trial of the drug as a second-line therapy for small cell lung cancer (SCLC). billion in 2018. million) in sales for the product in the first six months of this year, a rise of 30% at constant exchange rates.
In 2018, Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) was cleared by NICE in England – via the Cancer Drugs Fund (CDF) – as well as in Scotland by the SMC as a first-line option for treating ROS1-positive advanced NSCLC in adults.
The company is also looking at applications including pain during childbirth or trauma, or tackling the discomfort caused by some treatments such as cancer chemotherapy. Lower back pain is one of the top causes of disability around the world, and according to a 2018 report in The Lancet accounts for 189 million lost working days and $62.4
Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumour expresses a certain level of PD-L1. 0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, where tumours expressed PD-L1 (CPS ?
Tisagenlecleucel has been accessible through the NHS Cancer Drugs Fund since December 2018, and the new guidance advocates for its standardised distribution across the NHS. months for blinatumomab and three months for salvage chemotherapy, which are among the other standard treatments.
J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy. The median durations of response were 10 months and seven months, respectively.
Data from trials of the drug wowed ESMO in September – Trodelvy was shown to significantly extend overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared with standard chemotherapy in TNBC patients with brain metastases treated with at least two therapies. months, compared with 6.7
The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients.
The main object of the deal is Merck’s MEK 1/2 inhibitor pimasertib, a drug it originally licensed from Santhera Pharmaceuticals more than a decade ago, bringing the drug to phase 2 in melanoma and ovarian cancer and running trials in various other solid tumours and blood cancers before shelving it in 2018.
In June, Clovis suffered another blow when it withdrew Rubraca’s mCRPC approval, after a post-marketing trial showed a higher death rate with the drug compared to chemotherapy when used as a third- or later-line treatment for the cancer.
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.
Tibsovo (ivosidenib) was already on the market when Servier made its play for Agios’ assets, having secured US approvals as a treatment for relapsed or refractory IDH1-mutant AML in 2018 and as a monotherapy for newly diagnosed IDH1-mutant AML in patients aged over 75 or unable to take chemotherapy in 2019.
A phase 3 trial of the PD-1 inhibitor in cervical cancer patients who had progressed after first-line chemotherapy has been stopped early after an interim look at the data showed that the drug cut mortality by 31% compared to second-line chemo. The median overall survival with Libtayo (cemiplimab) was 12 months, compared to 8.5
Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.
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. The drug was the lead asset in Novartis’ $2.1
Keytruda (pembrolizumab) was being reimbursed on an interim basis for advanced or metastatic urothelial carcinoma, following platinum based chemotherapy, by the Cancer Drugs Fund (CDF) until survival data from a larger study emerged.
The FDA now says it will fast track review of DKN-01 as a second-line therapy for DKK-positive G/GEJ cancers after prior fluoropyrimidine- and platinum- containing chemotherapy as well as anti-HER2 drugs if those have been deemed appropriate. The post FDA fast-tracks Leap’s gastric cancer immunotherapy appeared first on.
Shares in US biotech Five Prime Therapeutics more than tripled after it reported promising trial results with stomach cancer drug candidate bemarituzumab, returning the stock to levels not seen since 2018. In the study, the median PFS improved from 7.4 months to 9.5 Median overall survival was 12.9
At an interim analysis, Lynparza (olaparib) reduced recurrence of disease compared to placebo in women with BRCA-mutated, HER2-negative breast cancer after surgery and chemotherapy to remove the tumour.
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