FDA’s OCE publishes three final guidances to increase clinical trial enrollment

Community sites have the patients to boost trial enrollment—but not the infrastructure

I have spent over 20 years running a tumor imaging metrics core at an academic cancer center. In that time, I have watched clinical trial enrollment concentrate at a relatively small number of flagship academic institutions. Unfortunately, trials do not propagate well to the community sites where most patients prefer to receive care. The explanations usually offered for why this happens have never fully accounted for what I observed.

Tarlatamab + durvalumab extends survival for patients with aggressive small cell lung cancer, phase III trial finds

In patients with extensive-stage small cell lung cancer, tarlatamab, a bispecific T-cell engager, plus durvalumab as first-line maintenance therapy extended median overall survival by more than eight months, more than tripled progression-free survival, and reduced the risk of death by 58% compared to durvalumab alone, according to the results of the phase III open-label, multicenter, randomized DeLLphi-305 study.

November 06, 2026

Vol.52 No.41

Drugs & Targets

FDA approves Rybrevant Faspro as dual-targeted therapy for advanced head and neck cancer

FDA granted accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) (subcutaneous injection, 160 mg/2,000 units per mL) as a single agent for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed on or after platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody.

November 06, 2026

Vol.52 No.41

Drugs & Targets

FDA grants priority review to Brukinsa combination for first-line mantle cell lymphoma

FDA accepted and granted Priority Review to the supplemental New Drug Application for Brukinsa (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma.

November 06, 2026

Vol.52 No.41

Podcast

Cercek: “The majority of patients in AZUR-1 in a global study were able to avoid all of standard of care”

On Oct. 19, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli) for the treatment of patients with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability–high, as determined by an FDA-authorized test.

November 04, 2026

Clinical

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

Earlier this week, FDA granted an accelerated approval to dostarlimab-gxly (Jemperli), for adults with previously untreated stage 2 or stage 3 rectal cancer that is mismatch repair deficient or microsatellite instability-high, marking a celebratory moment for the field.

October 30, 2026

Vol.52 No.40

By Jacquelyn Cobb

FDA’s OCE publishes three final guidances to increase clinical trial enrollment

YOU MAY BE INTERESTED IN

Community sites have the patients to boost trial enrollment—but not the infrastructure

Tarlatamab + durvalumab extends survival for patients with aggressive small cell lung cancer, phase III trial finds

FDA approves Rybrevant Faspro as dual-targeted therapy for advanced head and neck cancer

FDA grants priority review to Brukinsa combination for first-line mantle cell lymphoma

Cercek: “The majority of patients in AZUR-1 in a global study were able to avoid all of standard of care”

MSK’s Andrea Cercek: Oncology faces learning curve as dostarlimab challenges dMMR rectal cancer standard of care

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