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

MAY 5, 2021

months in patients with high PD-L1 expression compared with standard chemotherapy. of people receiving chemotherapy. Last week, FDA advisers voted to keep Tecentriq as a treatment for triple negative breast cancer, during a review of several cancer drugs quickly approved on the basis of early data.

Chemotherapy 98

Chemotherapy FDA 98

pharmaphorum

MARCH 9, 2021

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy.

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FDA Chemotherapy 98

pharmaphorum

JULY 2, 2021

The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment option for patients with PD-L1-expressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received two or more earlier lines of therapy.

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FDA Chemotherapy Immunization 52

pharmaphorum

MAY 19, 2021

The FDA has accepted Eli Lilly and China’s Innovent filing for their latecomer immunotherapy sintilimab, which is expected to compete on price with rivals such as Merck & Co’s Keytruda. The US lung cancer dossier was submitted to the FDA in March, mainly based on the results of the phase 3 ORIENT-11 trial.

FDA 52

FDA Chemotherapy 52

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 90

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).

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FDA Chemotherapy Labelling 98

pharmaphorum

OCTOBER 22, 2021

The European Commission has given a green light to Opdivo (nivolumab) with chemotherapy for previously-untreated patients with HER2-negative oesophageal, gastric and gastroesophageal junction (GEJ) cancer whose tumours express the PDL-1 biomarker with a score of five or more.

Chemotherapy 104

Chemotherapy Immunization FDA 104

pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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FDA Chemotherapy Vaccines 104

pharmaphorum

JANUARY 26, 2021

The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the most common form of bladder cancer – in cases where cancer hasn’t progressed after platinum-containing chemotherapy. The green light in Europe comes six months after the FDA backed the same use for the drug in the US.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

JUNE 30, 2021

The European Commission cleared Keytruda (pembrolizumab) alongside chemotherapy for previously-untreated patients with oesophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma with PD-L1 combined positive score of 10 or more. months over chemotherapy.

Chemotherapy 52

Chemotherapy FDA 52

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 83

Chemotherapy FDA Labelling 83

pharmaphorum

AUGUST 4, 2021

Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients with non-small cell lung cancer (NSCLC). The FDA is due to make a decision on the application by 1 December, according to Roche.

FDA 52

FDA Chemotherapy 52

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”

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FDA Chemotherapy Immunization 120

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.

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FDA Chemotherapy Labelling 109

pharmaphorum

OCTOBER 14, 2021

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. 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.

Chemotherapy 44

Chemotherapy Research Laboratories Immunization FDA 44

pharmaphorum

JULY 28, 2021

Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. It’s the latest in a string of positive developments for Keytruda in breast cancer.

Chemotherapy 57

Chemotherapy FDA 57

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 109

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. The post FDA clears Seagen, Genmab’s Tivdak ADC for cervical cancer appeared first on.

FDA 52

FDA Chemotherapy Labelling 52

pharmaphorum

AUGUST 22, 2021

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. ” The post BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy appeared first on.

FDA 76

FDA Chemotherapy Immunization 76

pharmaphorum

JANUARY 18, 2021

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. Until now people with AL amyloidosis have had to rely on chemotherapy, with its accompanying side effects, and other drugs to tackle organ failure once damage gets severe.

Chemotherapy 98

Chemotherapy FDA 98

pharmaphorum

NOVEMBER 9, 2021

Lung cancer drug Opdivo administered with chemotherapy has been shown to boost survival rates in patients with resectable non-small cell lung cancer (NSCLC). Also, Bristol-Myers Squibb was recently successful in gaining FDA approval for Opdivo to be used as an earlier line treatment for post-surgical treatment of invasive bladder cancer.

Chemotherapy 57

Chemotherapy Immunization FDA 57

pharmaphorum

NOVEMBER 18, 2021

A virtual reality system developed by AppliedVR that has been shown in trials to help reduce chronic lower back pain has been approved by the FDA as a prescription digital therapeutic (DTx). The post AppliedVR’s virtual reality therapy for pain cleared by FDA appeared first on.

FDA 98

FDA Chemotherapy 98

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 83

Chemotherapy Labelling FDA 83

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

MARCH 2, 2021

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.

FDA 57

FDA Research Laboratories Chemotherapy 57

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 28, 2021

Roche’s Tecentriq can stay on the US market as a therapy for triple negative breast cancer, advisers to the FDA have said as part of a review of several quickly-approved cancer drugs. While the ODAC’s vote is non-binding the FDA rarely goes against the advice of its expert advisers.

FDA 52

FDA Chemotherapy 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 69

Chemotherapy Labelling FDA 69

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

pharmaphorum

FEBRUARY 2, 2021

Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections. It may get the nod before GlaxoSmithKline’s dostarlimab , also under review at the FDA for endometrial cancer.

Chemotherapy 40

Chemotherapy FDA 40

pharmaphorum

OCTOBER 29, 2021

Trodelvy has already established itself as a go-to therapy for TNBC patients whose disease has progressed after prior treatments, says Gilead, while Keytruda is approved as a first-line therapy for the cancer in combination with chemotherapy, in patients with PD-L1 scores of 10 or more.

Chemotherapy 52

Chemotherapy FDA 52

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. Findings showed Sarclisa reduce risk of disease progression or death by 45% compared with standard of care in patients treated with one to three therapy lines.

Adverse Reactions 59

Adverse Reactions Labelling Chemotherapy FDA 59

pharmaphorum

JUNE 21, 2021

The EMA has cleared Onureg (formerly CC-486) as the first-ever orally-active drug that can be used for frontline maintenance treatment of AML who are in remission after initial chemotherapy but are not eligible for potentially curative therapies like a stem cell transplant. months from 14.8 months in a placebo-treated group.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

SEPTEMBER 13, 2021

Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a second-line treatment for oesophageal cancer. The FDA review has an action date of 12 July next year. The post First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab appeared first on.

FDA 52

FDA Chemotherapy 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.

Chemotherapy 98

Chemotherapy Labelling FDA 98