FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment
Pharmafile
MARCH 4, 2024
Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority review.
FDA Accepts sBLA for Dostarlimab With Chemotherapy to Treat Endometrial Cancer
Pharmacy Times
APRIL 25, 2024
Dostarlimab plus chemotherapy is the only immuno-oncology-based therapy that showed statistically significant and clinically meaningful survival benefit in the overall patient population.
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FDA Approves Tislelizumab-jsgr for Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy
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.
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As Chemotherapy Drug Shortage Continues, Unimaginable Decisions and Lacking Accountability Reign
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.
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?
FDA Approves Nivolumab Plus Chemotherapy for Unresectable or Metastatic Urothelial Carcinoma
Drug Topics
MARCH 8, 2024
A clinical trial showed that nivolumab plus chemotherapy significantly improved overall survival and progression-free survival compared with a chemotherapy combination alone.
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STAT+: FDA will allow troubled chemotherapy maker to resume distribution of cancer drugs in short supply
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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FDA Approves Osimertinib With Chemotherapy for EGFRm NSCLC
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.
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FDA Approves Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy for Malignant Pleural Mesothelioma
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.
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'We can't forget about this': As chemotherapy shortage ebbs and flows, attention shifts to long-term solutions
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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FDA Approves First Therapy for New HER2-low Breast Cancer Subtype
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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Topical Minoxidil Improves Hair Growth in 87% of Pediatric Patients With Chemotherapy-Induced Alopecia
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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FDA approves Amgen’s Imdelltra for extensive-stage small cell lung cancer
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 Approves Pembrolizumab With Chemotherapy to Treat Adult Patients With Endometrial Carcinoma
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.
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Sanofi’s immunotherapy Libtayo gets FDA not in first line lung cancer
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.
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FDA Approves Durvalumab for Treatment of Adults Patients With LS-SCLC
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.
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FDA Expands Approval of Dostarlimab-Gxly Plus Chemotherapy to All Adults With Primary, Recurrent Endometrial Cancer
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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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer
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 Approves Nivolumab for the Treatment of Adult Patients With Resectable NSCLC
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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FDA Approves Pembrolizumab Plus Chemotherapy to Treat Metastatic HER2-Negative Gastric, Gastroesophageal Junction Adenocarcinoma
Pharmacy Times
NOVEMBER 17, 2023
The approval makes pembrolizumab the first-line treatment for individuals with this cancer.
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FDA rejects Clovis' long-shot bid for approval of Rubraca
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 pulls AZ’s Evusheld for COVID, citing lack of efficacy
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 Accepts BLA for Datopotamab Deruxtecan for the Treatment of NSCLC
Pharmacy Times
FEBRUARY 20, 2024
Datopotamab deruxtecan is an investigational TROP2 directed antibody drug conjugate that showed positive survival impact compared to chemotherapy.
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Tagrisso-chemo cleared in US as 1st-line lung cancer therapy
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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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag
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 Grants Priority Review to Trastuzumab Deruxtecan for HER2-low, HER2 Ultralow Breast Cancer
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.
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FDA pushes Daiichi Sankyo’s quizartinib approval date by three months
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 Approves Enfortumab Vedotin, Pembrolizumab for Treatment of Urothelial Cancer
Pharmacy Times
DECEMBER 18, 2023
The approval marks the first for an alternative to platinum-containing chemotherapy.
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BMS, Mirati's Krazati cements lead over Amgen's Lumakras with FDA approval in colorectal cancer
Fierce Pharma
JUNE 24, 2024
FDA granted an accelerated approval for BMS’ KRAS inhibitor Krazati plus Eli Lilly’s Erbitux (cetuximab) to treat certain chemotherapy-experienced adults with KRAS-mutated locally advanced or metastatic colorectal cancer. Late Friday, the U.S.
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FDA Accepts sBLA for Tisotumab Vedotin-tftv for the Treatment of Recurrent, Metastatic Cervical Cancer
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.
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FDA grants approval to Gilead Sciences’ breast cancer therapy
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
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FDA clears Xalkori for inflammatory myofibroblastic tumours
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 Approves Amivantamab-Vmjw and Lazertinib for First-Line Treatment of NSCLC
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).
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FDA Approves Pembrolizumab Resectable Non–Small Cell Lung Cancer
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.
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'Extremely concerning' chemo shortage persists despite FDA's efforts, national cancer group reports
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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FDA approves innovative gene therapy for MLD
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.
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AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy
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.
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Pharmacosmos picks up G1 Therapeutics, FDA-approved drug Cosela in merger worth $405M
Fierce Pharma
AUGUST 7, 2024
The companies will team up to expand the reach of G1's Cosela, which is used to reduce bone marrow damage associated with certain chemotherapy regimens. In a deal worth approximately $405 million, Danish drugmaker Pharmacosmos has agreed to acquire G1 Therapeutics and the latter company's flagship product Cosela. |
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FDA Approves Tremelimumab Plus Durvalumab With Chemotherapy for Metastatic Non-Small Cell Lung Cancer
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.
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FDA Approves Libtayo, Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer
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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FDA Approves New Chemotherapy-Free Treatment Option for Metastatic Colorectal Cancer
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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STAT+: Springworks wins FDA approval for drug to treat desmoid tumors
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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First Immunotherapy Combo Treatment Approved for Biliary Tract Cancers
Drug Topics
SEPTEMBER 14, 2022
FDA approves durvalumab to treat biliary tract cancer in combination with chemotherapy.
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FDA Approves Merck's Keytruda With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma
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.
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