FDA Approval Annual Inventory (Part II) | Lung Cancer and Melanoma

On January 25, the U.
S.
Food and Drug Administration (FDA) approved tebentafusp-tebn for adult patients
with HLA-A*02:01 positive unresectable or metastatic uveal melanoma.

On March 4, nivolumab in combination with platinum-containing double-agent chemotherapy was approved by the FDA as neoadjuvant therapy
for resectable adult patients with non-small cell lung cancer (NSCLC).

On March 18, nivolumab + relatlimab-rmbw combination (Opdualag) was approved for unresectable or metastatic melanoma
.

On July 14, the FDA approved crizotinib for the treatment of adults or children ≥ 1 years of age with unresectable, relapsed, or refractory ALK-positive inflammatory myofibroblastoma (IMT
).

On August 10, capmatinib was approved for use in adult patients
with MET exon 14 skipping mutation metastatic NSCLC.

On August 11, trastuzumab deruxtecan (DS-8201) received accelerated FDA approval for adult patients
with HER2 mutation unresectable or metastatic NSCLC who had previously received systemic therapy.

On September 21, the FDA accelerated approval of the selpercatinib extended indication for patients with locally advanced or metastatic solid tumors positive for RET gene fusion
.

On November 8, the FDA approved cemiplimab-RWLC in combination with platinum-based chemotherapy for adults without EGFR, ALK or ROS1 mutations with advanced NSCLC
.

On November 10, the FDA approved tremelimumab in combination with duvalumab and platinum-based chemotherapy for adults without EGFR or ALK driver gene transfer NSCLC
.

On December 9, the FDA approved atezolizumab for adults with unresectable or metastatic acinar soft tissue sarcoma (ASPS) and children 2 years of age and older
.

On December 12, the FDA accelerated approval of adagrasib for patients
with locally advanced or metastatic NSCLC with KRAS G12C mutations who have received at least one prior systemic therapy.

January 25