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Luckily, there’s a shot to help prevent it: Shingrix, the shingles vaccine. The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California.
Vitamin D supplementation increased 25-hydroxyvitamin-D levels significantly, suggesting a potential role in enhancing chemotherapy effectiveness. The study's findings support further research with larger samples to explore vitamin D's impact on chemotherapy and breast cancer remission likelihood.
Benmelstobart (TQB2450; Chia Tai Tianqing Pharmaceutical Group Co, Ltd) in combination with chemotherapy followed by sequential combination with anlotinib (Catequentinib; Advenchen Laboratories) led to significant improvements in progression-free survival (PFS), with a manageable safety profile. months versus 7.79 months with tislelizumab.
The FDA's decision represents progress in treating EGFR-mutated NSCLC beyond initial therapy lines. SHOW MORE Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.
The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.
1 Biomarker testing is relatively new in the treatment landscape for NSCLC but has proven incredibly important for personalizing patient care, transforming from a generic chemotherapy approach to a highly personalized, genomically driven treatment strategy. For advanced disease, chemotherapy was the standard.
Meloxicam injection (Xifyrm; Azurity Pharmaceuticals, Inc) received FDA approval for use in adults for the management of moderate-to-severe pain, either alone or in combination with non-steroidal anti-inflammatory drug (NSAID) analgesics.
Transportation barriers, as a health-related social need, significantly impact FN rates in chemotherapy patients. Febrile neutropenia (FN) remains a serious and common complication of chemotherapy. A 67% FN rate difference between pegfilgrastim and filgrastim was observed in patients with transportation barriers.
Mok : Right now, we have a lot of chemotherapy being used, but there are many more novel treatments being studied, especially in earlier lines of treatment. Bispecifics are moving up in the lymphoma space, and these newer therapies may have some synergistic effects with chemotherapy. REFERENCES 1. Updated August 18, 2021.
Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. N Engl J Med. 2019;380:2020-2030. Subscribe Now!
The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.
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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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.
Approximately 40% to 80% of patients with cancer who are assigned female at birth face possible infertility as a result of their cancer treatments, such as chemotherapy, radiation, and surgery. An additional 15% to 30% of cancer survivors who are assigned male at birth also face infertility as a result of chemotherapy.
Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. Subscribe Now!
2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. In October 2024, CAR T therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) received FDA regenerative medicine advanced therapy designation as a first-line treatment for high-risk large B-cell lymphoma.
Dalton shared her surprise about how variability in manufacturing affects the patient experience, given that some products created using the patient’s cells may not always be usable or up to FDA standards. 2 For Dyke’s team, balancing research and commercial pathways have created gray areas.
Conclusions We demonstrated the feasibility of leveraging a complex EHR data source from an integrated health system to study the impact of dose modifications on clinical outcomes for self-administered chemotherapy. Nearly half of the patients with CML on imatinib experienced dosage modifications in this study.
It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. months, compared with 6.7
Darkow noted that, unlike a “typical” medication, biologics are larger, and for these reasons, products can encompass a wide range of types of forms, such as certain vaccines, blood products, monoclonal antibodies, cellular therapies, and insulin. The FDA approval process for biologics is lengthier compared with biosimilars.
Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.
link] Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now! Martino, PharmD, BCOP, APh Kaitlyn Wells, PharmD Sam Martinez, PharmD, BCOP, BCPS Craig A. Stevens, PharmD, BCPS June 3rd 2025 S2.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Yes, we currently have antibody-drug conjugates that are conjugated to a cytotoxic chemotherapy. I know the FDA is very interested in using real-world data to help inform and confirm some of the benefits that we are seeing in trials. We look at ADCs. Unfortunately, these drugs are quite toxic.
Blood cancer patients are usually at higher risk due to prior chemotherapy, and maybe we don’t need the same kind of prophylactic medications for solid tumor patients. I think we’re getting to the point now where hematology and oncology both need services that can manage these types of side effects. The infection risks are a little different.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Non-muscle invasive bladder cancer is characterised by cancer cells that remain only in the lining of the bladder.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
In England for instance, the introduction of a biosimilar to prevent neutropenia in patients undergoing chemotherapy, resulted in a number of Strategic Health Authorities reassessing their guidance relating to this medicine. Unpleasant truth: let’s embrace it and take action.
Keytruda is indicated in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. It is also indicated for the treatment of metastatic transitional (urothelial) tract cancer and gastric cancer.
The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. Increased reluctance to authorise innovative and unproven drugs for use, stemming from the FDA’s experience with Aduhelm, reduced the overall novel approvals in 2022. months longer on the treatment.
The CheckMate 816 trial showed a high pathological complete response rate without increased adverse events, supporting nivolumab as a standard treatment. A 5-year follow-up confirmed sustained overall survival benefits, with a notable reduction in mortality risk for patients achieving pathological complete response.
Both are brand-name drugs approved by the Food and Drug Administration (FDA) and are given as subcutaneous injections. They also have different FDA approvals for some conditions. Enbrel is FDA approved for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The phase 3 ECHO trial showed significant progression-free survival improvement with acalabrutinib, supporting its approval as a new standard of care for untreated MCL.
Recent successes in FDA approvals of antibody–drug conjugates (ADCs), RNA therapeutics and the UK’s regulatory leadership in coronavirus vaccines show that complex medicines are having a global impact. But the benefits of complex medicines go far beyond those we have seen with these vaccines.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Related Videos Related Content Advertisement June 9th 2025 Neoadjuvant Nivolumab With Chemotherapy Yields Significant Overall Survival Benefit in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2. Subscribe Now!
link] Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now!
Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. The post FDA fast-tracks Leap’s gastric cancer immunotherapy appeared first on.
After learning of his diagnosis, our relationship shifted from small talk at school events to detailed discussions in an infusion center setting about chemotherapy, immunotherapy, clinical trials, alternative medicines, and anticipated adverse effects.
They are] administered by the same nurses who would normally give chemotherapy’, Dr Tucker says. However, she adds that ‘approaches using, for example, T-cell stimulating vaccines are currently being explored’. Undoubtedly, much more research, development and clinical applications of bispecific antibodies can be expected.
GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with a specific mutation. That was due last Friday, but cancelled when GSK opted to withdraw the approval.
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