Pharmacy Times

JULY 24, 2023

Treatment providers have been forced to adapt and make potentially life-altering decisions for patients due to persistent chemotherapy drug shortages, all while solutions from the FDA and drug manufacturers remain scant.

Chemotherapy 123

Chemotherapy FDA 123

Pharmacy Times

MARCH 14, 2024

Results from the phase 3 RATIONALE 302 trial showed tislelizumab-jsgr prolonged survival compared to chemotherapy in patients who received prior systemic treatment.

Chemotherapy 123

Chemotherapy FDA 123

STAT

JUNE 6, 2023

After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some   cancer medicines that are in short supply.

Chemotherapy 99

Chemotherapy FDA Documentation 99

Pharmacy Times

SEPTEMBER 18, 2024

The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 227/KEYNOTE-483 trial.

Chemotherapy 139

Chemotherapy FDA 139

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.

FDA 132

FDA Chemotherapy 132

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

Pharmafile

MAY 17, 2024

Amgen has announced that the US Food and Drug Administration (FDA) has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have had disease progression on or after platinum-based chemotherapy.

FDA 111

FDA Chemotherapy 111

Pharmacy Times

JUNE 18, 2024

The indication is for adult patients with primary advanced or recurrent endometrial carcinoma and is the third indication that pembrolizumab has received for this disease state.

Chemotherapy 121

Chemotherapy FDA 121

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 116

FDA Chemotherapy 116

Pharmacy Times

MARCH 18, 2024

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

Chemotherapy 132

Chemotherapy FDA 132

Pharmacy Times

MARCH 14, 2025

Tarlatamab was approved by the FDA in May 2024 for patients who progressed after platinum-based chemotherapy.

Chemotherapy 119

Chemotherapy FDA 119

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

FDA 105

FDA Chemotherapy Labelling 105

Pharmacy Times

AUGUST 1, 2024

The RUBY trial will continue and analyze the overall population survival after treatment with the drug combination.

Chemotherapy 123

Chemotherapy FDA 123

Pharmacy Times

OCTOBER 4, 2024

Nivolumab is the only PD-1 inhibitor to show statistically significant and clinically meaningful benefits in non-small cell lung cancer compared with chemotherapy.

Chemotherapy 132

Chemotherapy FDA 132

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.

Chemotherapy 87

Chemotherapy FDA 87

Pharmacy Times

NOVEMBER 17, 2023

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

Chemotherapy 123

Chemotherapy FDA 123

Pharmacy Times

DECEMBER 5, 2024

The indication is for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemotherapy and radiation therapy.

Chemotherapy 123

Chemotherapy FDA 123

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Preliminary results from that study showed a 53.8%

FDA 111

FDA Chemotherapy 111

Pharmacy Times

OCTOBER 2, 2024

The designation was based on results from the DESTINY-Breast06 trial, evaluating fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) compared with chemotherapy.

Chemotherapy 123

Chemotherapy FDA 123

Pharmacy Times

DECEMBER 18, 2023

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

Chemotherapy 122

Chemotherapy FDA 122

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy showed 3.2

FDA 105

FDA Adverse Reactions Chemotherapy Labelling 105

Pharmacy Times

AUGUST 20, 2024

The combination is the first and only multi-targeted chemotherapy-free regimen that demonstrated superiority compared with osimertinib for non–small cell lung cancer (NSCLC).

Chemotherapy 115

Chemotherapy FDA 115

pharmaphorum

JULY 15, 2022

Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form of benign tumour that typically affects children and young adults. The post FDA clears Xalkori for inflammatory myofibroblastic tumours appeared first on.

FDA 116

FDA Chemotherapy Labelling 116

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

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)

Chemotherapy 124

Chemotherapy FDA 124

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

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 139

FDA Chemotherapy Labelling 139

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

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

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

PharmExec

NOVEMBER 9, 2023

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

Chemotherapy 59

Chemotherapy FDA 59

Pharmaceutical Commerce

NOVEMBER 17, 2023

Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer approved by FDA after being found to lower the risk of metastasis or death.

Chemotherapy 52

Chemotherapy FDA 52

European Pharmaceutical Review

AUGUST 2, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease. The post FDA approves innovative engineered cell therapy appeared first on European Pharmaceutical Review.

FDA 98

FDA Chemotherapy Immunization 98

European Pharmaceutical Review

MARCH 20, 2024

The US Food and Drug Administration (FDA) has approved gene therapy Lenmeldy (atidarsagene autotemcel) as the first treatment for children with early-onset metachromatic leukodystrophy (MLD). Deficiency of the enzyme arylsulfatase A (ARSA) and subsequent buildup of sulfatides in the cells is considered to cause MLD, FDA elucidated.

FDA 105

FDA Chemotherapy 105

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.”

FDA 122

FDA Chemotherapy Immunization 122

Pharmafile

AUGUST 5, 2024

PHILADELPHIA--GSK plc today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

Chemotherapy 59

Chemotherapy FDA 59

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.

FDA 98

FDA Chemotherapy 98