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).

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FDA Chemotherapy Labelling 98

pharmaphorum

NOVEMBER 30, 2021

The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, after granting the application a priority review. The post AZ eyes FDA verdict on Lynparza in adjuvant breast cancer in Q1 appeared first on. million new cases per year.

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FDA Chemotherapy Labelling 111

pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved,” said Gad, who is chairman and president of Y-mAbs. “I

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FDA Chemotherapy Labelling 105

pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

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FDA Chemotherapy Labelling 111

pharmaphorum

OCTOBER 4, 2021

Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough status for the drug that should shorten its review time. The post Enhertu nabs speedy FDA review for earlier use in breast cancer appeared first on. AZ paid a hefty $1.4

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FDA Chemotherapy Labelling 78

European Pharmaceutical Review

DECEMBER 5, 2022

PSMAfore, is a Phase III, open-label, multi-centre, 1:1 randomised study comparing the efficacy and safety of Pluvicto to a change in ARPI in 469 patients with PSMA–positive mCRPC. Regulatory approval will be discussed with the US Food and Drug Administration (FDA) in 2023. The PSMAfore study.

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Chemotherapy Compounding Labelling FDA 105

The Checkup by Singlecare

JUNE 17, 2024

When over-the-counter (OTC) remedies don’t cut it, your healthcare provider may prescribe Zofran ( ondansetron ), a medication used to treat upset stomach and prevent vomiting—especially when caused by chemotherapy, radiation therapy, and surgery. It’s also can be used off-label to treat morning sickness during pregnancy.

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Chemotherapy Dosage Packaging Hospitals 105

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

Chemotherapy 98

Chemotherapy FDA Labelling 98

Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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FDA Chemotherapy Labelling Immunization 52

pharmaphorum

AUGUST 8, 2022

The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that was once lumped under the HER2-negative classification. The post AZ gets FDA nod for Enhertu in first HER2-low cancer appeared first on.

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FDA Chemotherapy Labelling 52

pharmaphorum

SEPTEMBER 21, 2021

Antibody-drug conjugate (ADC) specialist Seagen has claimed its fourth product approval in the US, getting the nod from the FDA for Tivdak as a second-line monotherapy for recurrent or metastatic cervical cancer. There’s no word yet on a price for Tivdak, which will launch with a black box warning for ocular toxicity on its label.

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FDA Chemotherapy Labelling 52

The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. By Larry K.

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FDA Controlled Substances Chemotherapy Compounding 69

pharmaphorum

APRIL 29, 2021

That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional approvals in six cancers that subsequently failed studies designed to confirm their benefits.

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Labelling FDA Chemotherapy 52

pharmaphorum

SEPTEMBER 26, 2022

The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.

Chemotherapy 98

Chemotherapy Labelling FDA 98

pharmaphorum

OCTOBER 19, 2020

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The post FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies appeared first on.

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Adverse Reactions FDA Chemotherapy Labelling 59

pharmaphorum

JUNE 23, 2021

KEYNOTE-826 enrolled 600 patients with both PD-L1-positive and PD-L1-negative tumours who were treated with a regimen of Keytruda and chemotherapy, given either with or without Roche’s Avastin (bevacizumab). The post In a class first, Merck’s Keytruda extends survival in cervical cancer appeared first on.

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Chemotherapy FDA Labelling 85

The Checkup by Singlecare

NOVEMBER 21, 2024

Adults and children weighing more than 40 kg (88 lbs) Adults, children, and infants 1 month and older Conditions treated by famotidine and pantoprazole Famotidine is FDA-approved to treat stomach ulcers and duodenal ulcers, while pantoprazole is often prescribed off-label for both ulcerative conditions. pylori) in the stomach.

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Labelling Insurance FDA Chemotherapy 98

Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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FDA Chemotherapy Labelling 52

pharmaphorum

JUNE 11, 2021

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences.

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Chemotherapy Labelling FDA 83

pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.

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Chemotherapy Labelling FDA 52

pharmaphorum

DECEMBER 13, 2021

“The current standard of care consisting of chemotherapy and transplant is not effective at curing most patients with high risk relapsed large B-cell lymphoma, representing a huge unmet need in our field,” commented Manali Kamdar of the University of Colorado Cancer Centre, a TRANSFORM investigator.

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Chemotherapy Labelling FDA 98

European Pharmaceutical Review

JANUARY 23, 2023

About the Phase III trial for pancreatic ductal adenocarcinoma NAPOLI 3 is a randomised, open-label Phase III trial of Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for metastatic pancreatic ductal adenocarcinoma.

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Chemotherapy Labelling FDA 104

pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 The FDA has granted an accelerated approval based on data from the ongoing phase 1 GARNET trial, meaning that GSK will have to produce survival data for the drug to remain on the market in the long term.

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FDA Chemotherapy Labelling 52

pharmaphorum

MARCH 8, 2021

AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.

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Chemotherapy Labelling FDA 98

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.

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Chemotherapy Labelling FDA 105

pharmaphorum

AUGUST 31, 2022

The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with platinum-based doublet chemotherapy and checkpoint inhibitor therapy.

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Chemotherapy FDA Labelling 64

pharmaphorum

SEPTEMBER 25, 2020

Furthermore, the duration of response with the PD-1 checkpoint inhibitor was nearly five times longer at 29 months versus just over six months with frontline chemotherapy. of the chemo group.

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Chemotherapy Labelling Patient Care FDA 75

pharmaphorum

APRIL 1, 2021

The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. This adds to the competition against Johnson & Johnson’s multiple myeloma drug Darzalex (daratumumab), which the French pharma hopes that Sarclisa will outperform.

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Adverse Reactions Labelling Chemotherapy FDA 59

European Pharmaceutical Review

OCTOBER 19, 2023

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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Chemotherapy Compounding Immunization FDA 105

pharmaphorum

AUGUST 6, 2021

Keytruda (pembrolizumab) dominates first-line NSCLC treatment, where it is approved both as a monotherapy and in combination with chemotherapy, but a lengthening list of rivals has been nipping at its heels. The FDA has started its review of the application and is due to deliver a verdict by 4 December.

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Chemotherapy Labelling FDA 69

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

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Chemotherapy Labelling FDA 59

pharmaphorum

APRIL 30, 2021

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients. .

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Chemotherapy FDA Labelling 59

pharmaphorum

MARCH 24, 2022

Novartis has been steadily investing in radiopharmaceuticals over the last few years, and one of those deals has just paid off with an FDA approval for Pluvicto, the first targeted radioligand therapy for prostate cancer. After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7

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Chemotherapy Labelling FDA 59

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

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FDA Communication Chemotherapy Labelling 52

Hospital Pharmacy Europe

NOVEMBER 21, 2022

In fact, trastuzumab in combination with chemotherapy is a treatment option for patients with HER2-positive advanced gastric cancer. In a second phase 2 trial with HER2-positive advanced gastric cancer patients, researchers compared T-Dx-T with a physician’s choice of chemotherapy. months a progression-free survival of 5.6

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Chemotherapy Labelling Hospitals FDA 52

pharmaphorum

AUGUST 9, 2022

The data provide proof-of-principle for the use of MET-targeting drugs to offset Tagrisso resistance, and charts a way forward towards regulatory approvals of the combination as an alternative to chemotherapy for these patients. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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Chemotherapy Labelling FDA 52

pharmaphorum

APRIL 20, 2021

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings. . Both have been granted an FDA priority review with an action date of 17 August.

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Chemotherapy FDA Compounding Labelling 52