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.

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Chemotherapy FDA Documentation 101

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.

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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

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

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.

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FDA Chemotherapy 111

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

MAY 1, 2025

Liposomal annamycin demonstrates broad synergistic activity with multiple FDA-approved chemotherapies across hematologic and solid tumors in preclinical models, offering a promising and safer combination strategy for resistant and high-risk cancers.

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Chemotherapy FDA 73

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.

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Chemotherapy FDA 132

Pharmacy Times

AUGUST 1, 2024

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

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Chemotherapy FDA 123

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 87

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

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%

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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

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

Pharmacy Times

DECEMBER 18, 2023

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

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Chemotherapy FDA 122

Fierce Pharma

NOVEMBER 6, 2023

As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S., two high-ranking Republican lawmakers are pressing the | As shortages of drugs like amoxicillin, penicillin, Adderall and certain chemotherapies continue to confound doctors and patients in the U.S.,

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Chemotherapy FDA 92

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.

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FDA Chemotherapy Labelling 116

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

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

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

NOVEMBER 9, 2022

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial.

Chemotherapy 52

Chemotherapy FDA Adverse Reactions 52

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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FDA Chemotherapy Labelling Immunization 124

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.

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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

STAT

NOVEMBER 27, 2023

There are no currently approved therapies for desmoid tumors, but doctors often treat patients with chemotherapy, off-label targeted therapies, radiation, and surgery. The tumors do not spread to other parts of the body but can cause severe disability and pain in the tissues that they impact, like muscle or nerves.

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Chemotherapy FDA Labelling 123

STAT

DECEMBER 4, 2023

Many childhood cancers are still treated with intensive chemotherapies developed decades ago that leave virtually all survivors with severe or life-threatening conditions such as hearing loss, heart disease, or secondary cancers later in life.

Chemotherapy 134

Chemotherapy FDA 134

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.

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FDA Chemotherapy Immunization 98

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

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 122

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