Indications Withdrawn as FDA Evaluates Several Accelerated Approvals
To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.
Lung Cancer
USPSTF Expands Eligibility for Annual Lung Cancer Screening
Adults aged 50 to 80 years with 20 pack-year smoking history who currently smoke or quit within last 15 years should be screened with low-dose CT
Trial Investigating Canakinumab for Advanced or Metastatic NSCLC Misses Primary End Point
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to interleukin-1beta.
MPR Weekly Dose Podcast 70
This week we have news of an indication for the cancer treatment, Keytruda, being withdrawn; Janssen’s single dose vaccine gains Emergency Use Authorization; There’s findings on the effectiveness of ivermectin as a therapy for mild COVID-19; And devices to treat migraine and prevention of sub-concussive head impacts are authorized for marketing.
Lorbrena Approved for First-Line Treatment of ALK-Positive Metastatic NSCLC
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
Cosela Now Available to Reduce Chemotherapy-Induced Bone Marrow Suppression in ES-SCLC
The approval was based on data from 3 randomized, placebo-controlled trials that included 245 adults with ES-SCLC.
Keytruda Indication for Metastatic Small Cell Lung Cancer Withdrawn
Continued approval of the indication was contingent upon establishing the superiority of Keytruda as determined by overall survival.
Libtayo Cleared for Frontline Use in Advanced NSCLC With High PD-L1 Expression
The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.
Sotorasib Under Review for KRAS G12C-Mutated Locally Advanced or Metastatic NSCLC
The Food and Drug Administration has placed sotorasib under priority review for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
FDA Greenlights Cosela to Reduce Chemotherapy-Induced Bone Marrow Suppression in ES-SCLC
The Food and Drug Administration (FDA) has approved trilaciclib (Cosela; G1 Therapeutics, Inc.).
