FDA Approval of Oncology Drugs in March 2024

The FDA has approved several oncology therapies in March for diseases including non-small cell lung cancer (NSCLC), two different subsets of acute lymphoblastic leukemia (ALL), esophageal squamous cell carcinoma, and pretreated gynecologic cancers, among other types.

Here is a select list of oncology drugs that received FDA approval in March.

FDA Approves Amivantamab Plus Chemo for Advanced NSCLC With EGFR Exon 20 Insertion Mutations

On March 1, 2024, the FDA approved amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.¹ A traditional FDA approval was also granted to amivantamab for adult patients with locally advanced or metastatic NSCLC with EGFR insertion mutations whose disease progressed on or after platinum-based chemotherapy.

FDA Approves Inotuzumab Ozogamicin for Pediatric Patients With ALL

The FDA has granted approval for inotuzumab ozogamicin (Besponsa) as a treatment option for pediatric patients with relapsed or refractory CD22-positive ALL.² The approval is based on findings from a study in which 42% of patients achieved complete remission with a median duration of 8.2 months. Inotuzumab ozogamicin was previously approved in 2017 for the treatment of adults with relapsed or refractory B-cell precursor ALL.

Tislelizumab Approved by FDA for Unresectable or Metastatic Pretreated ESCC

The FDA has approved tislelizumab-jsgr (Tevimbra) for the treatment of patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.³ This decision comes after results from the phase 3 RATIONALE 302 trial (NCT03430843), demonstrating improved overall survival and progression-free survival with the PD-1 inhibitor tislelizumab compared with chemotherapy.

FDA Approves Ponatinib Plus Chemo for Newly Diagnosed Ph+ ALL

The FDA has granted approval for ponatinib (Iclusig) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive ALL.⁴ This decision stems from results observed in the PhALLCON trial (NCT03589326), showing a 30% minimal residual disease-negative complete remission rate with ponatinib plus chemotherapy compared with 12% in patients assigned imatinib (Gleevec) plus chemotherapy.

FDA Grants Full Approval to Mirvetuximab Soravtansine for Pretreated Gynecologic Cancers

The FDA has granted full approval to mirvetuximab soravtansine (Elahere) for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were treated with 1 to 3 prior systemic treatment regimens.⁵ The approval was based on findings from the Study 0416/MIRASOL trial (NCT04209855), which demonstrated improvements in overall survival and progression-free survival in patients treated with mirvetuximab soravtansine compared with those treated with chemotherapy.

References

1. FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications. News release. FDA. March 1, 2024. Accessed March 1, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications
2. FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia. News release. FDA. March 6, 2024. Accessed March 6, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-pediatric-patients-acute-lymphoblastic-leukemia
3. BeiGene receives FDA approval for Tevimbra for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. News release. BeiGene, Ltd. March 14, 2024. Accessed March 14, 2024. https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/
4. FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. News release. FDA. March 19, 2024. Accessed March 19, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-ponatinib-chemotherapy-newly-diagnosed-philadelphia-chromosome
5. FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 22, 2024. Accessed March 22, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian