Follow-up data for Imfinzi + Imjudo shows OS benefit in unresectable HCC

Imfinzi + chemo shows improved EFS and OS in muscle-invasive bladder cancer

Positive results from the NIAGARA phase III trial showed Imfinzi (durvalumab)in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves neoadjuvant/adjuvant Imfinzi for resectable NSCLC

FDA approved durvalumab (Imfinzi) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA accepts Bristol Myers Squibb’s sBLA for Opdivo + Yervoy in unresectable HCC

FDA accepted Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma.

September 06, 2024

Vol.50 No.33

Drugs & Targets

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

September 06, 2024

Vol.50 No.33

Clinical Roundup

Calquence combination significantly improved PFS in CLL in phase III trial

Positive high-level results from an interim analysis of the AMPLIFY phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia.

August 02, 2024

Vol.50 No.31

Drugs & Targets

EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.

July 26, 2024

Vol.50 No.30

Follow-up data for Imfinzi + Imjudo shows OS benefit in unresectable HCC

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Imfinzi + chemo shows improved EFS and OS in muscle-invasive bladder cancer

FDA approves neoadjuvant/adjuvant Imfinzi for resectable NSCLC

FDA accepts Bristol Myers Squibb’s sBLA for Opdivo + Yervoy in unresectable HCC

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

Calquence combination significantly improved PFS in CLL in phase III trial

EMA validates application for BMS’s Opdivo + Yervoy for unresectable or advanced HCC

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