pharmaphorum

AUGUST 4, 2021

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).

FDA 98

FDA Chemotherapy Labelling 98

pharmaphorum

SEPTEMBER 6, 2022

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

Chemotherapy 103

Chemotherapy Immunization FDA 103

European Pharmaceutical Review

SEPTEMBER 29, 2023

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 ).

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Chemotherapy Immunization 111

European Pharmaceutical Review

JULY 5, 2022

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.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

Pharmaceutical Technology

JUNE 1, 2023

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.

FDA 97

FDA Chemotherapy 97

pharmaphorum

JUNE 4, 2021

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.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

JANUARY 26, 2023

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.

Chemotherapy 96

Chemotherapy Immunization Hospitals 96

pharmaphorum

APRIL 27, 2021

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.

FDA 90

FDA Chemotherapy Documentation 90

pharmaphorum

OCTOBER 6, 2022

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.

Generic Medicine 98

Generic Medicine Chemotherapy 98

Hospital Pharmacy Europe

FEBRUARY 23, 2023

A significant 5-year overall survival rate has been found following neoadjuvant nivolumab therapy in resectable non-small cell lung cancer According to a global 2018 study, lung cancer was the most commonly diagnosed cancer (11.6% The patient cohort was derived from the team’s earlier 2018 trial described above.

Hospitals 97

Hospitals Chemotherapy 97

pharmaphorum

JUNE 4, 2021

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.

Chemotherapy 88

Chemotherapy 88

pharmaphorum

JUNE 23, 2021

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.

Chemotherapy 85

Chemotherapy FDA Labelling 85

pharmaphorum

MARCH 25, 2022

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.

Chemotherapy 98

Chemotherapy 98

European Pharmaceutical Review

NOVEMBER 8, 2022

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.

Chemotherapy 52

Chemotherapy 52

pharmaphorum

AUGUST 11, 2022

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

Chemotherapy 64

Chemotherapy FDA 64

pharmaphorum

AUGUST 4, 2022

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.

Chemotherapy 105

Chemotherapy Labelling FDA 105

European Pharmaceutical Review

OCTOBER 19, 2023

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?

Chemotherapy 105

Chemotherapy Compounding Immunization FDA 105

pharmaphorum

SEPTEMBER 30, 2021

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.

Chemotherapy 52

Chemotherapy 52

pharmaphorum

JUNE 7, 2021

” 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

Chemotherapy 64

Chemotherapy Immunization 64

pharmaphorum

JANUARY 19, 2021

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.

Chemotherapy 98

Chemotherapy Immunization 98

pharmaphorum

NOVEMBER 18, 2021

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

FDA 98

FDA Chemotherapy 98

pharmaphorum

AUGUST 3, 2022

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.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

DECEMBER 4, 2020

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.

FDA 93

FDA Chemotherapy 93

pharmaphorum

OCTOBER 14, 2021

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 ?

Chemotherapy 45

Chemotherapy Research Laboratories Immunization FDA 45

pharmaphorum

DECEMBER 21, 2020

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

Chemotherapy 126

Chemotherapy Immunization FDA 126

Hospital Pharmacy Europe

APRIL 12, 2024

Final draft guidance for the treatment , which has been available through the NHS Cancer Drugs Fund (CDF) since December 2018, recommends tisagenlecleucel for children and young adults up to and including 25 years of age who have B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

Hospitals 52

Hospitals Chemotherapy 52

pharmaphorum

OCTOBER 19, 2020

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.

Adverse Reactions 59

Adverse Reactions FDA Chemotherapy Labelling 59

pharmaphorum

FEBRUARY 24, 2021

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.

Chemotherapy 83

Chemotherapy Compounding FDA 83

pharmaphorum

NOVEMBER 10, 2022

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.

Chemotherapy 59

Chemotherapy Labelling FDA 59

pharmaphorum

MARCH 24, 2022

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.

Chemotherapy 59

Chemotherapy Labelling FDA 59

pharmaphorum

AUGUST 2, 2021

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.

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

MARCH 15, 2021

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

Chemotherapy 52

Chemotherapy Vaccines 52

pharmaphorum

JANUARY 5, 2021

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.

Chemotherapy 52

Chemotherapy Immunization FDA Labelling 52

pharmaphorum

APRIL 11, 2022

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

Chemotherapy 52

Chemotherapy 52

pharmaphorum

MARCH 18, 2021

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.

Chemotherapy 52

Chemotherapy Documentation 52

pharmaphorum

SEPTEMBER 25, 2020

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.

FDA 72

FDA Immunization Chemotherapy Vaccines 72

pharmaphorum

NOVEMBER 12, 2020

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

Chemotherapy 52

Chemotherapy Immunization 52