FDA approves Retevmo for locally advanced or metastatic RET fusion-positive solid tumors, NSCLC

FDA opens application for Orphan Products Clinical Trials Grant Program

FDA is accepting applications for its Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01). This program is administered by the FDA’s Office of Orphan Products Development.

September 15, 2023

Vol.49 No.34

Clinical Roundup

Six-year outcomes from phase III CheckMate-227 show durable long-term survival with Opdivo + Yervoy in first-line treatment of mNSCLC

Six-year results from part 1 of the phase III CheckMate -227 trial demonstrate long-term, durable survival benefits of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression levels.

September 15, 2023

Vol.49 No.34

Clinical Roundup

Intensity-modulated radiation therapy provides long-term benefits in NSCLC

Intensity-modulated radiation therapy should be the preferred choice when treating patients with locally advanced non-small cell lung cancer, as it reduces radiation exposure to the heart and lungs, according to researchers at MD Anderson Cancer Center.

September 15, 2023

Vol.49 No.34

Clinical Roundup

Rybrevant drug combo demonstrates durable PFS in second-line EGFR-mutated NSCLC in CHRYSALIS-2 cohort

Follow-up results from the phase Ib/II CHRYSALIS-2 study cohort evaluating the safety and tolerability of the combination of Rybrevant (amivantamab-vmjw)—a bispecific antibody targeting epidermal growth factor receptor and mesenchymal-epithelial transition—with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor, plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer and EGFR mutations, showed that the drug combination led to durable progression-free survival.

September 15, 2023

Vol.49 No.34

Clinical Roundup

Phase III data demonstrate Alecensa reduces disease recurrence in the early setting for ALK-positive NSCLC

The phase III ALINA study evaluating Alecensa (alectinib) compared with platinum-based chemotherapy met its primary endpoint of disease-free survival at a prespecified interim analysis.

September 08, 2023

Vol.49 No.33

Drugs & Targets

FDA grants accelerated approval to Elrexfio for r/r multiple myeloma

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

September 08, 2023

Vol.49 No.33

FDA approves Retevmo for locally advanced or metastatic RET fusion-positive solid tumors, NSCLC

YOU MAY BE INTERESTED IN

FDA opens application for Orphan Products Clinical Trials Grant Program

Six-year outcomes from phase III CheckMate-227 show durable long-term survival with Opdivo + Yervoy in first-line treatment of mNSCLC

Intensity-modulated radiation therapy provides long-term benefits in NSCLC

Rybrevant drug combo demonstrates durable PFS in second-line EGFR-mutated NSCLC in CHRYSALIS-2 cohort

Phase III data demonstrate Alecensa reduces disease recurrence in the early setting for ALK-positive NSCLC

FDA grants accelerated approval to Elrexfio for r/r multiple myeloma

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