December 4th 2023
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.
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.
FDA Approves Adzynma for Congenital Thrombotic Thrombocytopenic Purpura
November 9th 2023Adzynma was previously granted a FDA Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations for patients with congenital thrombotic thrombocytopenic purpura.
FDA Restricts Keytruda Approval for Certain Patients With Gastric Cancer
November 9th 2023The FDA granted accelerated approved in May 2021 to pembrolizumab (Keytruda) plus trastuzumab (Herceptin), fluoropyrimidine, and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Expanded Indication for Abatacept to Treat Juvenile Psoriatic Arthritis
November 1st 2023Abatacept is indicated across multiple inflammatory conditions, including for the treatment of adult patients with moderately to severely active rheumatoid arthritis, pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis, and active juvenile psoriatic arthritis.
FDA Approves Interchangeable Ustekinumab Biosimilar for Inflammatory Diseases
November 1st 2023The FDA granted Wezlana with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions across multiple inflammatory diseases.
FDA Approves Keytruda Plus Chemotherapy for Biliary Tract Cancer
November 1st 2023The approval of pembrolizumab (Keytruda; Merck) combined with gemcitabine and cisplatin for the treatment locally advanced unresectable or metastatic biliary tract cancer is the sixth sixth indication for the anti-PD-1 therapy for gastrointestinal cancers.