SPOTLIGHT -
GSK Limits Use of Zejula for Some Cancer Patients
After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.
FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy
Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.
FDA Approves Liletta IUD to Prevent Pregnancy for 8 Years
The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.
FDA Accepts NDA for Generalized Myasthenia Gravis Therapy
Zilucoplan is a targeted therapy that inhibits key components in the underlying disease pathology. The anticipated PDUFA date is in the fourth quarter of 2023.
Protalix, Chiesi Resubmit BLA to Treat Fabry Disease
PRX-102 is an enzyme replacement therapy for Fabry disease, a rare genetic disorder.
FDA Clears Imfinzi/Imjudo Combination for Lung Cancer
Imjudo is a monoclonal antibody that targets the activity CTLA-4 that was approved to be used in combination with Imfinzi, a PD-L1 inhibitor, for patients with non-small cell lung cancer.
FDA Accepts NDA for Novel Parkinson’s Disease Therapy
IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.
FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma
In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death
FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization
If approved, Aphexdra would be used along with G-CSF treatment for autologous transplantation in patients with multiple myeloma. The Prescription Drug User Fee Act target action date is Sept. 9, 2023.
FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients
Kineret has been granted an EUA for hospitalized adults with pneumonia who require supplemental oxygen.
FDA Approves Libtayo for Second Indication in Advanced Lung Cancer
The new indication expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.
FDA Approves Melanoma Drug to Treat Blood Cancers
Cotellic, an oral inhibitor of MEK1 and MEK2, was approved to treat patients with histiocytic neoplasms based on a phase 2 trial conducted solely at Memorial Sloan Kettering Cancer Center.
FDA Approves Hepatitis B Therapy for Adolescents
This approval expands the use of Vemlidy to children 12 years of age and older. Vemlidy is already available for adults living with this chronic liver disease.
FDA Grants Priority Review for Adult RSV Vaccine
If approved, GSK’s vaccine could be the first available to help protect adults over the age of 60. The Prescription Drug User Fee Act date is May 3, 2023.
CytoDyn Withdraws BLA for HIV Therapy
The withdrawal is related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization.
FDA Again Extends Review for Pompe Disease Therapy
The FDA cited COVID-19-related travel restrictions that have impacted the agency’s inspection of a manufacturing site in China.
Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma
Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells
FDA Postpones Advisory Committee Meeting for OTC Birth Control
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma
Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.
FDA Grants Priority Review for Novel C. Difficile Therapeutic
If approved, SER-109 would be the first oral microbiome therapeutic available. The Prescription Drug User Fee Act action date is April 26, 2023.
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
FDA Clears Novel Liver Cancer Combo Treatment
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
FDA Accepts NDA for Novaliq’s New Dry Eye Therapy
Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.
FDA Accepts Supplemental Application for Camzyos
The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.
FDA Grants Six Months Pediatric Exclusivity for Eylea
Eylea is being reviewed as a treatment for retinopathy in premature infants.
Novavax COVID-19 Vaccine Booster Gets FDA EUA
Novavax’ protein-based vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
FDA Extends Review Time for Biogen’s ALS Therapy
If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.
FDA Accepts BLA for Hemophilia A Gene Therapy
If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. for the treatment of severe hemophilia A. A PDUFA action date has been set for March 31, 2023.
FDA Authorizes Updated COVID-19 Boosters for Younger Children
The bivalent booster vaccines add the omicron variant BA.4 and BA.5 to the original SARS-CoV-2 along with a component of omicron BA.1.
FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants
The FDA has assigned a target action date of Feb. 11, 2023.
