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Genmab and Pfizer’s TIVDAK sBLA secures full FDA approval

Pharmaceutical Business Review

During the trial, TIVDAK demonstrated a primary endpoint achievement of overall survival (OS) in patients with previously treated recurrent or metastatic cervical cancer, outperforming chemotherapy. The innovaTV 301 study showcased a 30% reduction in the risk of death when compared to chemotherapy, with a median OS of 11.5

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Evive, Acrotech get FDA nod for Ryzneuta (Efbemalenograstim alfa Injection) for chemo-induced neutropenia

Express Pharma

It helps to enhance the immune function of cancer patients and prevent the side effects of neutropenia caused by chemotherapy. Due to its unique molecular structure, Ryzneuta may possess stronger GCSF receptor activation properties and avoid the potential problem (such as allergic reactions) caused by PEG or Tween-80.

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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy. Enhertu’s safety profile was consistent with the previous clinical trials.

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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 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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FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

pharmaphorum

The FDA’s approval covers use of Venclexta (venetoclax) in combination with azacytidine, or decitabine, or low-dose cytarabine (LDAC) for newly diagnosed AML in adults 75 years or older, or who have comorbidities preventing intensive induction chemotherapy. months compared with 4.1 months for those treated with LDAC alone.

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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.