When did stage 3B lung cancer become “early stage”?

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.

Divarasib monotherapy improves OS in previously-treated KRAS G12C-mutated lung cancer, phase III trial finds

Divarasib, a next-generation KRAS G12C inhibitor, lowered the risk of disease progression or death by 42% and the overall risk of death by 44% in people with previously treated KRAS G12C-mutated non-small cell lung cancer, according to the results from the phase III Krascendo 1 study. The therapy demonstrated the superior efficacy compared with current standard of care KRAS G12C inhibitors.

October 30, 2026

Vol.52 No.40

Drugs & Targets

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA has expanded approval of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with homologous recombination repair gene mutations, including both BRCA and non-BRCA mutations.

October 30, 2026

Vol.52 No.40

Drugs & Targets

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA is accepting comments on a new regulatory framework that it published for industry sponsors developing personalized gene therapies to treat rare diseases.

FDA authorizes marketing of 24 nicotine pouches

FDA authorized the marketing of 24 nicotine pouch products through the premarket tobacco product application pathway. The authorized products are made by Modoral Brands Inc. under the Velo brand and are all listed as containing 4 mg of nicotine.

October 30, 2026

Vol.52 No.40

When did stage 3B lung cancer become “early stage”?

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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

Divarasib monotherapy improves OS in previously-treated KRAS G12C-mutated lung cancer, phase III trial finds

FDA expands approval of Talzenna + Xtandi for an earlier metastatic prostate cancer treatment setting

FDA releases guidance for sponsors developing gene therapies for rare diseases

FDA authorizes marketing of 24 nicotine pouches

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