FDA

The FDA's complete response letter was not related to clinical trial data for efficacy or safety for zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction.

Findings from the Phase III innovaTV 301 trial showed a favorable benefit/risk profile for Tivdak (tisotumab vedotin-tftv), as well as improved overall survival for patients with recurrent and metastatic cervical cancer who have limited treatment options.

Rinatabart sesutecan (Rina-S; PRO1184) is a novel folate receptor alpha (FRα)–targeted antibody-drug conjugate for patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

Data from the Phase III ZIRCON trial show the positron emission tomography imaging agent 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

Results from the Phase III BOND-003 trial demonstrated that treatment with CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) provided clinical benefit in complete responses with acceptable tolerability for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer.

EUA submission based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents.

A Phase II trial (NCT02446093) is currently investigating neoadjuvant therapy with aglatimagene besadenovec plus valacyclovir with standard chemoradiation and surgery for the treatment of patients with borderline resectable or locally advanced nonmetastatic pancreatic ductal adenocarcinoma.

Results from the Phase III OUtMATCH trial show Xolair significantly increased the amount of peanuts, milk, egg, and cashew that patients with food allergies could consume before triggering an allergic reaction.

Garadacimab was previously granted orphan drug designation for patients with hereditary angioedema by both the FDA and EMA.

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

If approved, Merck's V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease.

Adbry is the first and only biologic FDA-approved for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable.

Zoryve (roflumilast) topical foam, 0.3% is a highly potent and selective phosphodiesterase type 4 inhibitor in development to treat inflammatory dermatoses.

Results from the EV-302/KN-A39 clinical trial found that Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a median overall survival of 31.5 months compared to 16.1 months with platinum-based chemotherapy.

The Phase III SEACRAFT-2 trial will analyze the clinical efficacy of naporafenib compared with physician’s choice of single-agent dacarbazine, temozolomide, or trametinib among patients with NRAS-mutated metastatic melanoma who received prior treatment with an immunotherapy.

Trial findings show Welireg lowered the risk of disease progression or death compared to Afinitor in patients with advanced renal cell carcinoma whose disease progressed following treatment with a PD-1 or PD-L1 inhibitor and a TKI.

This is the first FDA approval of a therapy indicated to decrease the risk of relapse in pediatric patients with high-risk neuroblastoma.

MAPS Public Benefit Corporation has submitted a new drug application to the FDA for MDMA (midomafetamine capsules) for use with psychological intervention to treat post-traumatic stress disorder.

Phase II open-label, non-comparative, multicenter clinical trial shows Cresemba is effective in pediatric patients as young as 1 year of age with invasive aspergillosis and invasive mucormycotic.

Casgevy, which was approved along with Lyfgenia, is the first approval for a novel genome editing technology for sickle cell disease, which represents a significant advancement in gene therapy.

Clinical trials demonstrated superiority of Fabhalta to anti-C5s in hemoglobin improvement in the absence of transfusions and transfusion avoidance rate, showing clinically meaningful hemoglobin-level increases without the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria.

Johnson & Johnson’s TAR-200 is currently in clinical trials for patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for or elected not to receive bladder removal surgery.

Opdivo in combination with cisplatin-based chemotherapy shows durable responses and improved survival for patients with metastatic urothelial carcinoma.

Pirtobrutinib (Jaypirca) is a next-generation, highly selected, non-covalent BTK inhibitor that has shown nanomolar potency against wild-type and C481-mutant BTK in cell and enzyme assays.

Supplemental Biologics License Application submission based on data from the Phase 3 KEYNOTE-A39 trial comparing Keytruda plus Padcev with chemotherapy of gemcitabine plus cisplatin or carboplatin.

FDA grants to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for patients with ER–positive, HER2-negative advanced or metastatic breast cancer.

Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi and Sympazan.

KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies.

Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and a pair of Phase 1 pharmacokinetic studies for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older.

Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia.