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

FDA 76

FDA Chemotherapy Labelling 76

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

MARCH 13, 2022

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. The post AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy appeared first on.

FDA 133

FDA Chemotherapy Labelling 133

pharmaphorum

MAY 26, 2022

billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. It can be used in in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Servier is on course to get a return on its $1.8 for the control group.

FDA 52

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.

FDA 52

FDA Chemotherapy Labelling 52

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.

FDA 109

FDA Chemotherapy Labelling 109

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.

FDA 52

FDA Chemotherapy Labelling 52

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.

Chemotherapy 96

Chemotherapy Compounding Labelling FDA 96

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.

Chemotherapy 52

Chemotherapy Labelling FDA 52

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.

FDA 108

FDA Chemotherapy Labelling 108

Pharmaceutical Technology

MARCH 6, 2023

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

Chemotherapy 52

Chemotherapy FDA Labelling Immunization 52

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year.

FDA 52

FDA Chemotherapy Labelling 52

pharmaphorum

OCTOBER 25, 2021

The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. months to 23 months, according to data reported at this year’s ESMO cancer conference.

Chemotherapy 87

Chemotherapy FDA Labelling 87

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.

Adverse Reactions 57

Adverse Reactions FDA Chemotherapy Labelling 57

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

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.

FDA 52

FDA Chemotherapy Labelling 52

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.

FDA 52

FDA Communication Chemotherapy Labelling 52

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.

Chemotherapy 62

Chemotherapy FDA Labelling 62

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

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

Chemotherapy 57

Chemotherapy Labelling FDA 57

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.

Chemotherapy 52

Chemotherapy Labelling FDA 52

pharmaphorum

DECEMBER 5, 2022

Pluvicto becomes the first PSMA-targeted intravenous radioligand therapy – combining a targeting compound or ligand with a therapeutic radionuclide or radioactive particle (in this case, lutetium-177) – to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy.

Chemotherapy 57

Chemotherapy Compounding Labelling FDA 57

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

Chemotherapy 57

Chemotherapy Labelling FDA 57

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.

Adverse Reactions 53

Adverse Reactions Labelling Chemotherapy FDA 53

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.

Chemotherapy 69

Chemotherapy FDA Labelling 69

pharmaphorum

NOVEMBER 14, 2022

GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

Labelling 52

Labelling Chemotherapy FDA Vaccines 52

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. .

Chemotherapy 57

Chemotherapy FDA Labelling 57

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.

Chemotherapy 52

Chemotherapy FDA Compounding 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.

Chemotherapy 66

Chemotherapy Labelling FDA 66

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.

Chemotherapy 97

Chemotherapy Labelling FDA 97

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.

Chemotherapy 85

Chemotherapy Labelling FDA 85

pharmaphorum

FEBRUARY 7, 2022

The drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for this type of cancer in June 2021 based on results from the GARNET trial , which included women who progressed on or after platinum-based chemotherapy.

Chemotherapy 52

Chemotherapy Labelling FDA 52

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 103

Chemotherapy Labelling FDA 103

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. 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

The Checkup by Singlecare

OCTOBER 16, 2023

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Approved by the U.S.

Dosage 52

Dosage Insurance Coverage Labelling Insurance 52

Hospital Pharmacy Europe

NOVEMBER 6, 2023

Adagrasib is a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Hospitals 52

Hospitals Chemotherapy Labelling FDA 52

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.

Chemotherapy 56

Chemotherapy Labelling FDA 56