March 27th 2024
Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.
FDA Expands Indication for Adbry to Include Pediatric Patients With Atopic Dermatitis
December 19th 2023Adbry 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.
Padcev/Keytruda Combination Approved by FDA for Locally Advanced or Metastatic Urothelial Cancer
December 15th 2023Results 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.
FDA Fast Tracks Naporafenib for Unresectable, Metastatic Melanoma
December 15th 2023The 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.
LITESPARK-005 Trial Data Lead to FDA Approval of Welireg for Advanced Renal Cell Carcinoma
December 15th 2023Trial 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.
Key Phase III Trial Results Lead to FDA Approval of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria
December 6th 2023Clinical 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.
FDA Accepts sNDA for Roflumilast Following Promising Trial Results in Atopic Dermatitis
November 30th 2023Arcutis 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.
FDA Awards Breakthrough Designation to Epkinly for Follicular Lymphoma
November 27th 2023Epcoritamab-bysp (Epkinly; AbbVie and Genmab) is a T-cell engaging bispecific antibody under evaluation for the treatment of adults with follicular lymphoma that is relapsed or refractory following treatment with two or more therapies.
FDA Grants Fast Track Designation to Investigational Food Allergy Immunotherapy
November 27th 2023The FDA granted Fast Track Designation to ADP101 based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies.
Truqap Plus Faslodex Approved by FDA for Advanced HR+/HER2– Breast Cancer
November 17th 2023First-in-class combination of capivasertib (Truqap) plus fulvestrant (Faslodex) approved for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN biomarker alterations.
Keytruda Combination Gets FDA Approval for Gastric, GEJ Adenocarcinoma
November 17th 2023Merck’s pembrolizumab (Keytruda) combined with fluoropyrimidine- and platinum-containing chemotherapy approved for the first-line treatment of patients with locally advanced unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Augtyro Gets FDA Approval for Locally Advanced, Metastatic ROS1-Positive Non-Small Cell Lung Cancer
November 16th 2023The FDA's approval of Bristol Myers Squibb’s repotrectinib (Augtyro) was based on findings from the open-label, single-arm, Phase 1/2 trial TRIDENT-1, which evaluated the safety, tolerability, pharmacokinetics, and anti-tumor activity of the drug in patients with advanced solid tumors.