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FDA approves Regeneron’s Libtayo and chemotherapy combination for NSCLC

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial.

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Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. Nausea, fatigue, vomiting, reduced neutrophil count, alopecia and anaemia among others were observed to be the most prevalent adverse reactions.

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Gilead’s Trodelvy approved in metastatic urothelial cancer

pharmaphorum

Trodelvy (sacituzumab govitecan) has been approved for locally advanced or metastatic urothelial cancer, following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor immunotherapy. Adverse reactions leading to treatment discontinuation occurred in 10% of those receiving Trodelvy, with 4% discontinuing treatment due to neutropenia.

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FDA approves AbbVie-Genmab’s Epkinly to treat DLBCL

Pharmaceutical Technology

As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that Epkinly can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off-the-shelf form for physicians. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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US FDA approves Novartis’ Tafinlar and Mekinist combination therapy

Pharmaceutical Technology

According to the findings, participants treated with Tafinlar + Mekinist had a 47% overall response rate (ORR) compared to those who received chemotherapy.

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Gilead to Presents P-III (TROPiCS-02) Study Results of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer at ASCO 2023

PharmaShots

Shots: The P-III study (TROPiCS-02) evaluating Trodelvy vs CT in a ratio (1:1) in 543 patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and 2 chemotherapies In the exploratory analysis, improvement in m-OS benefit (14.5 vs 11.2mos.), PFS rates at 6/12/18mos. vs 29.4%)/ (21.7% vs 8.4%)/ (14.4%

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NMPA of China approves Takeda’s Exkivity for NSCLC

Pharmaceutical Technology

It has been approved to treat NSCLC patients with EGFR Exon20 insertion mutations, whose disease has advanced on or after they received platinum-based chemotherapy. Rash, decreased appetite, paronychia, and diarrhoea are the most common adverse reactions (TRAEs) related to the treatment.