FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

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.

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

Drugs & Targets

EC expands Padcev + Keytruda approval to adults with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility

The European Commission has granted Marketing Authorization for Padcev (enfortumab vedotin), in combination with Keytruda (pembrolizumab), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer in the European Union, regardless of cisplatin eligibility.

October 30, 2026

Vol.52 No.40

FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

YOU MAY BE INTERESTED IN

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

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

EC expands Padcev + Keytruda approval to adults with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility

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