Oncology Drugs Approved by the FDA in September 2024

Throughout the month of September, several cancer therapies were approved by the Food and Drug Administration (FDA) for diseases including breast cancer, multiple myeloma, non-small cell lung cancer (NSCLC) and thyroid cancer.

Here is a select list of oncology drugs that received FDA approval last month.

Subcutaneous Tecentriq Formulation for Several Cancer Types

The FDA approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), a subcutaneous injection, for the treatment of patients including those with NSCLC, hepatocellular carcinoma (HCC), melanoma and alveolar soft part sarcoma. A subcutaneous injection is typically delivered beneath the skin, whereas intravenous formulations, which is how the original version of Tecentriq (atezolizumab) is formulated, are administered into a vein.

The study for which this approval is based on demonstrated that there was a minimal difference regarding efficacy and survival with subcutaneous Tecentriq compared with its intravenous formulation.

Kisqali Regimen for HR-Positive, HER2-Negative Early Breast Cancer

Kisqali (ribociclib) received FDA approval with an aromatase inhibitor for the postsurgical treatment of patients with HR-positive, HER2-negative stage 2 and 3 early breast cancer with an increased risk for recurrence. At the same time, the agency also approved Kisqali plus Femara (letrozole) for the same indication.

“The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease [cancer that has not spread to the lymph nodes], is a pivotal moment in improving our approach to care,” said Dr. Dennis J. Slamon, Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator in a news release issued by manufacturer Novartis. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning.”

Sarclisa for Newly Diagnosed Transplant-Ineligible Multiple Myeloma

The FDA granted approval to Sarclisa (isatuximab-irfc) with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In the trial that supported this approval, the Sarclisa regimen demonstrated a 40% reduction in the risk of disease progression or death.

Sarclisa was previously approved by the FDA in 2020 with pomalidomide and dexamethasone for adults with multiple myeloma who received at least two prior therapies including lenalidomide and a proteasome inhibitor. It was also approved in 2021 with Kyprolis (carfilzomib) and dexamethasone for adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

Retevmo for Patients 2 Years and Older With Medullary Thyroid Cancer

Retevmo (selpercatinib) was approved by the FDA to treat adults and children aged 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation who require systemic therapy. Findings from the LIBRETTO-531 trial, which aided the agency in their decision on this therapy, demonstrated that the median progression-free survival (PFS, the time a patient lives without their disease spreading or worsening) was not reached in the Retevmo group compared with 16.8 months in the control group. Of note, when median progression-free survival is not reached in a trial, it means that at least half of the patients in the study have not experienced disease progression or death from any cause.

Retevmo previously received accelerated approval for this indication in patients aged 12 years and older in 2020. In May of 2024, the FDA granted accelerated approval to Retevmo for children aged 2 years and older.

Tagrisso for Locally Advanced, Unresectable Stage 3 NSCLC

The FDA approved Tagrisso (osimertinib) for patients with stage 3 NSCLC without progression during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations.

Tagrisso, the agency stated, displayed an improvement in progression-free survival, with a median PFS of 39.1 months in the Tagrisso group and 5.6 months in the placebo group in the LAURA trial, on which the approval was based. Overall survival (the time a patient lives regardless of disease status) results were not mature at the time of analysis, with 36% of pre-specified deaths for the final analysis reported, but the FDA stated that no trend towards a detriment had been observed.

Rybrevant Plus Chemo for NSCLC With EGFR Exon 19 Deletions or L858R Mutations

Rybrevant (amivantamab-vmjw) plus chemotherapy was approved by the FDA for locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R mutations. Based on the results of the MARIPOSA-2 trial, the median PFS was 6.3 months in patients from the Rybrevant combination group versus 4.2 months in the carboplatin-pemetrexed group. The confirmed objective response rate (ORR, patients who responded partially or completely to treatment) was 53% and 29% in the Rybrevant combination and carboplatin-pemetrexed groups.

Regarding safety, the most common side effects that occurred in at least 20% or more patients included rash, infusion-related reactions, nail toxicity, nausea, fatigue, constipation, edema (swelling caused by fluid in tissues), stomatitis (inflammation of the mouth and lips), decrease in appetite, musculoskeletal pain (pain to the muscles or joints), vomiting and COVID-19 infection.

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