September Roundup of FDA Approvals in Oncology: 8 Decisions to Know

Below is your guide to all the oncologic options that were given the green light by the FDA in September 2026. The regulatory roundup provides everything you need to know, right at your fingertips, including all the topline data that supported the decisions and expert insights detailing clinical practice implications.

9/4: Camizestrant Plus a CDK4/6 Inhibitor in Emergent ESR1-Mutated HR+/HER2– Advanced Breast Cancer

Indication: The FDA granted accelerated approval to camizestrant (Etcamah) plus a CDK4/6 inhibitor (abemaciclib [Verzenio], palbociclib [Ibrance], or ribociclib [Kisqali]) for the treatment of adult patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer that acquires an ESR1 mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, as identified by an FDA-approved test.

Supporting Data: The decision was supported by data from the phase 3 SERENA-6 trial (NCT04964934), which investigated a switch to oral camizestrant plus a CDK4/6 inhibitor vs continuing an aromatase inhibitor plus a CDK4/6 inhibitor in patients with a circulating tumor DNA (ctDNA)–detected ESR1 mutation and no evidence of radiographic progression on first-line endocrine-based therapy. The median progression-free survival (PFS) was 16 months (95% CI, 12.7-18.2) in the camizestrant arm (n = 157) vs 9.2 months (95% CI, 7.2-9.5) in the control arm (n = 158; HR, 0.44; 95% CI, 0.31-0.60; P < .00001). With longer follow-up presented at the 2025 San Antonio Breast Cancer Symposium, the median PFS values were 16.6 months (95% CI, 14.7-19.4) vs 9.2 months (95% CI, 7.2-9.7), respectively (HR, 0.46; 95% CI, 0.34-0.62; P < .00001).

Clinical Significance: The approval brings a ctDNA-guided strategy into practice, in which patients switch endocrine partners upon detection of an emergent ESR1 mutation and ahead of disease progression. Additional SERENA-6 analyses presented at the 2026 ASCO Annual Meeting showed a median PFS2 of 25.7 months (95% CI, 20.4-30.3) with camizestrant vs 19.1 months (95% CI, 16.8-21.0) with the control regimen (HR, 0.63; 95% CI, 0.46-0.86; P = .00373), and the PFS benefit was maintained in patients with PIK3CA (HR, 0.41) and TP53 (HR, 0.52) co-mutated disease. Overall survival data remain immature; continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial.

“The approval of camizestrant based on the data from SERENA-6 is incredibly important, not only for the approval of the agent itself, but also for the overall platform and structure in which it was approved,” Erica L. Mayer, MD, MPH, director of Breast Cancer Clinical Research in the Breast Oncology Program at Dana-Farber Cancer Institute and an associate professor of medicine at Harvard Medical School, said in an interview with OncLive^®.

9/9: Sevabertinib in HER2 TKD–Mutated Nonsquamous NSCLC

Indication: The FDA granted accelerated approval to sevabertinib (Hyrnuo) for the treatment of adult patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

Supporting Data: The approval was supported by data from the open-label, single-arm, multicenter, multicohort phase 1/2 SOHO-01 trial (NCT05099172). Among evaluable patients who had not received prior systemic therapy (n = 69), the overall response rate (ORR) was 75% (95% CI, 64%-85%); 73% of responders experienced a duration of response (DOR) of at least 6 months, and 38% had a DOR of at least 12 months.

In data published in The New England Journal of Medicine, the confirmed ORR among evaluable treatment-naive patients (n = 73) was 71% (95% CI, 59%-81%), with a median DOR of 11.0 months (95% CI, 8.1-not evaluable [NE]); the median PFS was NE (95% CI, 9.6 months-NE).

Clinical Significance: Sevabertinib provides a targeted option for patients with nonsquamous NSCLC harboring HER2 TKD activating mutations. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial.

9/14: Reduced Monitoring Time for Tarlatamab in Extensive-Stage SCLC

Indication: The FDA approved a labeling update that reduces the post-infusion monitoring period to 6 to 8 hours following the first two doses of tarlatamab-dlle (Imdelltra) in patients with extensive-stage small cell lung cancer (ES-SCLC).

Supporting Data: Tarlatamab's efficacy is supported by the open-label, randomized phase 3 DeLLphi-304 trial (NCT05740566), which compared tarlatamab with investigator's choice of chemotherapy in patients with ES-SCLC whose disease progressed on or after 1 line of platinum-based chemotherapy. Tarlatamab produced a median overall survival (OS) of 13.6 months (95% CI, 11.1-NE) vs 8.3 months (95% CI, 7.0-10.2) with chemotherapy (HR, 0.60; 95% CI, 0.47-0.77; P < .001). The median PFS was 4.2 months vs 3.2 months, respectively (HR, 0.72; 95% CI, 0.59-0.88; P < .001), and the respective ORRs were 35% vs 20%. In a pooled safety population (n = 472), any-grade cytokine release syndrome (CRS) occurred in 57% of patients, including grade 1 in 39%, grade 2 in 15%, grade 3 in 1.7%, and grade 4 in 0.2%, with a median time to onset of 16 hours.

Clinical Significance: The shorter monitoring window after the first 2 doses may reduce the logistical burden of initiating tarlatamab, which received traditional FDA approval in November 2025 for patients with ES-SCLC.

9/14: TLX101-Px for Glioma Imaging

Indication: TLX101-Px (Pixclara; floretyrosine F 18 [18F-FET]), a radioactive amino acid FET-PET imaging agent, received FDA approval to differentiate treatment-related changes from recurrent or progressive glioma, in combination with other diagnostic strategies, in adult and pediatric patients at least 1 month of age.

Supporting Data: TLX101-Px is an intravenous PET imaging agent labeled with fluorine-18 that targets the L-type amino acid transporters LAT1 and LAT2. Among 382 patients with glioma evaluated for safety (371 adults and 11 pediatric patients), the only adverse effect reported in at least 0.5% of patients was headache (0.5%), and the safety profile was consistent across adult and pediatric populations.

9/17: FDA Clears sNDA for Taletrectinib With Updated DOR Data in ROS1+ NSCLC

Indication: The FDA cleared a supplemental new drug application (sNDA) for taletrectinib (Ibtrozi), updating the label with new DOR data in TKI-naive patients with locally advanced or metastatic ROS1-positive NSCLC; the decision comes 4 months ahead of the Prescription Drug User Fee Act date.

Supporting Data: Updated pooled data from the phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials showed that at a median follow-up of 51 months, the median DOR was 49.7 months (95% CI, 41.3-not reached) among TKI-naive patients in TRUST-I (n = 103), in whom the ORR was 90% (95% CI, 83%-95%). The ORR was 85% (95% CI, 73%-93%) among TKI-naive patients in TRUST-II (n = 54). Among ROS1 TKI–pretreated patients, the ORRs were 52% (95% CI, 39%-64%) in TRUST-I (n = 66) and 62% (95% CI, 46%-75%) in TRUST-II (n = 47).

Clinical Significance: According to Nuvation Bio, the median DOR of more than 4 years is the longest reported for an FDA-approved ROS1 TKI, and its addition to the label gives physicians further evidence to support using taletrectinib early in a patient's care. Taletrectinib was initially approved by the FDA for ROS1-positive NSCLC in June 2025.

9/18: Imlunestrant Plus Abemaciclib in ER+/HER2– ESR1-Mutated Advanced Breast Cancer

Indication: The FDA approved imlunestrant (Inluriyo) plus abemaciclib for the treatment of adult patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, who experience disease progression after 1 or more lines of endocrine therapy.

Supporting Data: The decision was based on the randomized, open-label phase 3 EMBER-3 trial (NCT04975308), which enrolled 874 patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor alone or with a CDK4/6 inhibitor. Patients were randomly assigned 1:1:1 to imlunestrant, investigator's choice of endocrine therapy, or imlunestrant plus abemaciclib. In the exploratory ESR1-mutated subgroup (n = 159), the median PFS was 11.1 months (95% CI, 7.4-13.7) with imlunestrant plus abemaciclib (n = 67) vs 5.5 months (95% CI, 3.8-7.2) with imlunestrant monotherapy (n = 92; HR, 0.53; 95% CI, 0.35-0.80), and the ORRs were 35% vs 15%, respectively.

Clinical Significance: The approval adds an all-oral, imlunestrant-based combination for patients with ESR1-mutated disease after progression on endocrine therapy. Among 208 safety-evaluable patients who received the combination, grade 3/4 adverse effects included diarrhea (9%), infections (7%), and fatigue (5%).

9/23: Lirafugratinib in Previously Treated FGFR2-Rearranged Cholangiocarcinoma

Indication: The FDA approved lirafugratinib (Lyrfigtu) for the treatment of adult patients with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 gene fusion or other rearrangement.

Supporting Data: The decision was backed by data from the phase 1/2 REFOCUS trial (NCT04526106), in which lirafugratinib elicited an ORR of 46% (95% CI, 36%-55%) and a median DOR of 11.8 months (95% CI, 7.5-13.0). Findings presented at the 2026 ASCO Gastrointestinal Cancers Symposium showed that among 114 evaluable patients, the ORR was 46.5% (95% CI, 37.1%-56.1%), the disease control rate was 96.5% (95% CI, 91.3%-99.0%), and the median OS was 22.8 months (95% CI, 18.1-27.2).

Clinical Significance: Lirafugratinib represents an FGFR2-directed targeted therapy for patients with previously treated, FGFR2 fusion– or rearrangement–positive CCA. In the pivotal portion of the trial, patients received lirafugratinib at 70 mg once daily until disease progression or unacceptable toxicity.

9/24: Belzutifan Plus Lenvatinib in Advanced ccRCC After PD-1/PD-L1 Inhibition

Indication: The FDA approved belzutifan (Welireg) plus lenvatinib (Lenvima) for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) after a PD-1 or PD-L1 inhibitor.

Supporting Data: The approval was backed by data from the open-label, randomized, active-controlled phase 3 LITESPARK-011 trial (NCT04586231), in which the combination significantly improved PFS at a median of 14.6 months (95% CI, 11.1-16.6) vs 10.6 months (95% CI, 9.2-11.1) for vs cabozantinib (Cabometyx) monotherapy (HR, 0.74; 95% CI, 0.61-0.89; 1-sided P = .00095). The ORR was 53% (95% CI, 47%-58%) vs 40% (95% CI, 35%-45%), respectively (1-sided P = .0002).

Clinical Significance: Belzutifan plus lenvatinib offers a new combination option for patients with advanced ccRCC whose disease progressed after anti–PD-(L)1 therapy, improving PFS and response rate vs cabozantinib alone. The median OS was numerically longer with the combination (33.7 vs 28.6 months; HR, 0.85; 95% CI, 0.70-1.03), though the difference was not statistically significant.