Pharmacy Times

FEBRUARY 19, 2024

Osimertinib was previously approved as a monotherapy, the first-in-line global standard of care, for non–small cell lung cancer indications.

Chemotherapy 120

Chemotherapy FDA 120

Pharmaceutical Commerce

FEBRUARY 19, 2024

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

Chemotherapy 52

Chemotherapy FDA 52

PharmExec

MARCH 7, 2024

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

Chemotherapy 52

Chemotherapy FDA 52

Fierce Pharma

SEPTEMBER 27, 2023

It’s been about 10 months since FDA inspectors rebuked a | As some cancer centers struggle to secure access to key platinum-based chemotherapies, a national spotlight gives the issue newfound political importance. But will this be a turning point for the recurrent shortage issue? ASCO's Julie Gralow, M.D., certainly hopes so.

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Chemotherapy FDA 108

Pharmaceutical Technology

FEBRUARY 19, 2024

The US FDA has granted approval for AstraZeneca's Tagrisso regimen for EGFRm non-small cell lung cancer (NSCLC) in adults.

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Chemotherapy FDA 52

PharmExec

NOVEMBER 17, 2023

Merck's pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative GEJ adenocarcinoma.

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Chemotherapy FDA 52

PharmExec

NOVEMBER 9, 2023

Fruquintinib (Fruzaqla) is the first novel chemotherapy-free treatment option approved for metastatic colorectal cancer in more than a decade.

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Chemotherapy FDA 59

Pharmacy Times

MARCH 18, 2024

The FDA-approved topical and oral agent is currently indicated for adult patients with patterned alopecia.

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Chemotherapy FDA 132

Pharmacy Times

NOVEMBER 11, 2022

Tremelimumab-actl (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy approved for the treatment of adults with metastatic non–small cell lung cancer without sensitizing EGFR mutation or ALK aberrations.

Chemotherapy 65

Chemotherapy FDA 65

Pharmaceutical Technology

MARCH 15, 2024

The US FDA has approved BeiGene's TEVIMBRA for oesophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy.

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FDA Chemotherapy 52

PharmExec

FEBRUARY 19, 2024

The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC.

Chemotherapy 52

Chemotherapy FDA 52

Pharmacy Times

AUGUST 5, 2022

The FDA approved a new drug that treats unresectable and metastatic HER2-low breast cancer, giving patients with this new subtype a treatment beyond chemotherapy.

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FDA Chemotherapy 132

Pharmacy Times

NOVEMBER 9, 2022

Efficacy results comparing the cemiplimab-rwlc combination to chemotherapy alone showed a 22-month median overall survival versus 13 months.

Chemotherapy 65

Chemotherapy FDA 65

Pharmacy Times

FEBRUARY 20, 2024

Datopotamab deruxtecan is an investigational TROP2 directed antibody drug conjugate that showed positive survival impact compared to chemotherapy.

Chemotherapy 121

Chemotherapy FDA 121

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The median OS in patients on quizartinib was 31.9

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FDA Chemotherapy 98

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. months for the chemotherapy arm. months compared with 5.1 months compared with 16.8

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FDA Chemotherapy Labelling 105

PharmExec

JANUARY 19, 2024

Today's FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.

FDA 52

FDA Chemotherapy 52

pharmaphorum

FEBRUARY 19, 2024

AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)

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Chemotherapy FDA 124

Pharmacy Times

NOVEMBER 17, 2023

The approval makes pembrolizumab the first-line treatment for individuals with this cancer.

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Chemotherapy FDA 123

Fierce Pharma

JUNE 5, 2023

But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.

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FDA Chemotherapy 97

Pharmafile

NOVEMBER 17, 2023

The approval follows data from the phase 3 […] The post FDA approves Merck’s Keytruda for gastric cancer treatment appeared first on Pharmafile.

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FDA Chemotherapy 59

PharmExec

DECEMBER 1, 2023

The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

FDA 59

FDA Chemotherapy 59

Pharmaceutical Commerce

JANUARY 19, 2024

Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.

FDA 52

FDA Chemotherapy 52

Pharmacy Times

JANUARY 9, 2024

The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.

Chemotherapy 122

Chemotherapy FDA 122

Pharmacy Times

OCTOBER 17, 2023

Pembrolizumab (Keytruda) gains its sixth approval in non–small cell lung cancer (NSCLC), with the latest indication in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a monotherapy for the post-surgical adjuvant treatment of patients with resectable NSCLC.

Chemotherapy 123

Chemotherapy FDA 123

Pharmaceutical Commerce

NOVEMBER 1, 2023

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

Chemotherapy 52

Chemotherapy FDA 52

PharmExec

NOVEMBER 1, 2023

The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.

Chemotherapy 52

Chemotherapy FDA 52

PharmExec

DECEMBER 5, 2023

The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

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FDA Chemotherapy 52

Pharmacy Times

DECEMBER 18, 2023

The approval marks the first for an alternative to platinum-containing chemotherapy.

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Chemotherapy FDA 122

Pharmaceutical Technology

DECEMBER 6, 2023

The US FDA has accepted Bristol Myers Squibb’s sBLA for Opdivo plus cisplatin-based chemotherapy as a first-line treatment

FDA 52

FDA Chemotherapy 52

Pharmaceutical Technology

NOVEMBER 17, 2023

The US FDA has granted approval for Merck’s Keytruda plus chemotherapy as a first-line treatment for adult gastric cancer patients.

FDA 52

FDA Chemotherapy 52

Fierce Pharma

OCTOBER 6, 2023

While the White House recently touted the FDA’s efforts to mitigate the ongoin | The National Comprehensive Cancer Network found that 72% of centers are still experiencing a carboplatin shortage, while 59% remain low on cisplatin. The survey follows a June report which found that nearly all centers had short supply of the chemotherapies.

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Chemotherapy FDA 128

PharmExec

DECEMBER 15, 2023

In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.

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 59

Chemotherapy Immunization FDA 59

Pharmaceutical Commerce

DECEMBER 1, 2023

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

Chemotherapy 110

Chemotherapy FDA 110

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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FDA Chemotherapy Immunization Vaccines 135

pharmaphorum

FEBRUARY 23, 2021

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy.

FDA 112

FDA Chemotherapy 112