In this episode of Targeted Talks, Edwin Choy, MD, PhD, discussed the FDA approval of afamitresgene autoleucel for the treatment of patients with advanced synovial sarcoma. In this episode of Targeted Talks, Edwin Choy, MD, PhD, director of the sarcoma program at the Division of Hematology Oncology at Massachusetts General Hospital, a founding member of Mass General Brigham, and associate professor of medicine at Harvard Medical School, delves into the recent approval of afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of patients with advanced synovial sarcoma.

Breaking New Ground in Synovial Sarcoma: Choy on the FDA Approval of Afami-cel

Investigators are on track to launch part 2 of the phase 1 Deltacel-01 trial in September 2024. Treatment with the investigational, allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy KB-GDT-01 (Deltacel™) may elicit a progression-free survival (PFS) benefit among patients with stage IV metastatic non–small cell lung cancer (NSCLC), according to interim results from part 1 of the phase 1 Deltacel-01 trial (NCT06069570).1.

Novel T-Cell Therapy May Show PFS Benefit in Stage IV Metastatic NSCLC

A new drug application has been submitted to the FDA for UGN-102, an intravesical solution for treating low-grade, intermediate-risk non–muscle-invasive bladder cancer. The FDA has received a new drug application (NDA) seeking the approval of mitomycin for intravesical solution (UGN-102) for treating patients with low-grade, intermediate-risk, non–muscle-invasive bladder cancer (NMIBC).

FDA Considers UGN-102 in Low-Grade NMIBC

SurvivorNet

A rare form of endometrial cancer - uterine serous carcinoma – is more aggressive in Black women compared to white women, according to a new study published in the medical journal Proceedings of the National Academy of Sciences.

As Howard Stern’s Sidekick Robin Quivers, 71, Embraces ‘Bald Hairdo’ Amid Endometrial Cancer, New Study Finds a Rare Form of the Cancer Is More Aggressive In Black Women

Avidity Biosciences‘ delpacibart zotadirsen, or del-zota for short — formerly called AOC 1044 — was found to safely increase levels of dystrophin production to 25% of normal in people with Duchenne muscular dystrophy (DMD), according to new data from the EXPLORE44 trial. In the Phase 1/2 clinical...

Del-zota increases dystrophin in DMD patients, new trial data show

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases. This article was originally published on The Center for Biosimilars®. Sandoz secured another approval, this time for an aflibercept biosimilar.1 Enzeevu (aflibercept-abzv) is the fourth...

FDA Approves Biosimilar Enzeevu for Eye Conditions

Incorporating information from common blood tests can enhance cancer risk assessment in patients with abdominal symptoms, according to a study publishing July 30th in the open-access journal PLOS Medicine by Meena Rafiq from University College London, UK, and colleagues. Early cancer detection is key to successful treatment. However, many undiagnosed...

Routine blood test results can improve cancer risk assessment in patients with abdominal symptoms

Researchers have demonstrated that adding metastasis-directed radiation therapy to standard-of-care chemotherapy may improve progression-free survival in patients with oligometastatic pancreatic cancer, according to a recent study published by Ludmir et al in the Journal of Clinical Oncology and previously presented at the 2024 ASCO Gastrointestinal Cancers Symposium (Abstract 603). Background.

Metastasis-Directed Radiation Therapy Plus Chemotherapy in Oligometastatic Pancreatic Cancer

The Food and Drug Administration (FDA) on Aug. 6 approved VORANIGO, the first targeted therapy for Grade 2 Isocitrate dehydrogenase (IDH) mutant glioma, a type of brain tumor. Available to patients as a once-daily pill, VORANIGO is the first significant treatment breakthrough in nearly 25 years for Grade 2 IDH mutant glioma, the drug’s maker Servier explained.

FDA approves Servier’s VORANIGO for certain brain tumors

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NewsNinja

"They accidentally gave us 2 washers and a dryer when we only ordered 1 of each". Last month, Lowe’s experienced a glitch that lowered the price of its $2,300 Midea jumbo capacity refrigerator to just $169.

‘Lowe’s messed up’: Shopper says they got $2,300 fridge at Lowe’s for just $169

Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week. The FDA has granted accelerated approval for Livdelzi (seladelpar) to treat patients with primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). PBC is a progressive autoimmune disease that results from the destruction of the bile ducts in the liver. This leads to inflammation, scarring and cirrhosis. The disease affects mostly women.

FDA Grants Accelerated Approval for Rare Liver Disease Drug

Enzeevu is biosimilar to Eylea (aflibercept), which was FDA-approved in 2019. Sandoz announced today the FDA approval of biosimilar Enzeevu (aflibercept-abzv) for the treatment of neovascular age-related macular degeneration, according to the details of a news release published this morning. Enzeevu is interchangeable with reference medication Eylea (aflibercept) with unexpired exclusivity. The recommended dose of Enzeevu is a 2 mg intravitreal injection administered every four weeks for the first three months and then every eight weeks for two months.

Biosimilar Enzeevu Approved by FDA to Treat Neovascular Age-Related Macular Degeneration

The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

Colorado State

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David Heitz

A bill quietly introduced this spring in the Colorado legislature to decriminalize the possession of drug paraphernalia obtained by harm reductionists has become law. As low-key as the legislation was introduced, the bill was signed into law without fanfare June 6. It garnered little to no media attention.

Colorado legalizes needles, pipes for meth and crack if obtained by harm reduction group

Cooking With Maryann

This recipe is sooo tasty! It truly is for garlic lovers! It involves sautéing onions and mushrooms in butter and oil until golden, then adding wine to reduce. Garlic, thyme, and parsley are stirred in for flavor, followed by seasoning with salt and pepper. The dish is garnished with additional parsley and served warm, making for a savory, aromatic side. Here's what you'll need to make it:

Garlic Mushrooms in Brown Butter Herb Sauce

Thyroid cancer stages range from 1 to 4 (sometimes referred to in Roman numerals as I, II, III, and IV). Stage 4 thyroid cancer is the most serious; stage 1 is the least severe. The stage of someone's cancer is determined by the size and spread of cancer cells from a tumor's primary site, in this case, the thyroid gland.

What Are the Stages of Thyroid Cancer?

Health

Medically reviewed by Marla Anderson, MDMedically reviewed by Marla Anderson, MDNon-small cell lung cancer (NSCLC) is a type of cancer that begins in the tissues of the lungs. About 80-85% of all lung cancer cases in the United States are classified as NSCLC. NSCLC occurs when the cells that line the surface of the lung airways change and mutate. When these abnormal cells rapidly divide and multiply, they lead to cancer. The most common cause of NSCLC is smoking, with about 90% of lung cancer cases being related to tobacco smoke exposure. It is possible to be diagnosed with NSCLC if you...

What Causes Non-Small Cell Lung Cancer (NSCLC)?

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,...

Lomecel-B granted FDA RMAT status for mild Alzheimer’s

Florida State

Jacksonville Today

Republican Donald Trump has a 7-point lead over Democrat Kamala Harris among Florida voters, 49% to 42%, according to a new poll from the University of North Florida. Four percent are backing another candidate, and 6% are undecided or didn’t answer.

New Florida poll: Trump leads; support strong for abortion and recreational weed

Neoadjuvant/adjuvant sacituzumab govitecan showed encouraging intratumoral concentrations in patients with brain metastases as well as glioblastoma. The antibody-drug conjugate (ADC), sacituzumab govitecan (Trodelvy), given in the neoadjuvant and adjuvant settings, displayed promising preliminary activity in patients undergoing craniotomy for breast cancer with brain metastases or those with recurrent glioblastoma (GBM), according to a phase 0 window-of-opportunity study (NCT03995706) published in Nature Communications.

Sacituzumab Govitecan Shows Preliminary Activity in Patients With Brain Mets, GBM

NewsBreak

FDA Grants Fast Track Designation to Deltacel and Radiation in NSCLC

Following promising data from the phase 1 Deltacel-01 trial, the FDA has given Deltacel plus low-dose radiation therapy a fast track designation in stage IV non–small...

FDA Grants Fast Track Designation to Deltacel and Radiation in NSCLC

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