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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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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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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The FDA approval is based on the data obtained from a global, multicentre, open-label Phase III TROPiCS-02 study conducted in 543 HR+/HER2- metastatic breast cancer patients who have received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease. Trodelvy showed 3.2

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US FDA approves Incyte’s merkel cell carcinoma therapy

Pharmaceutical Technology

Zynyz monotherapy showed a 52% objective response rate (ORR) in chemotherapy-naïve patients. Diarrhoea, rash, pyrexia, nausea, musculoskeletal pain, fatigue and pruritus are the most common adverse reactions observed in patients treated with Zynyz. Partial response was seen in 22 patients and complete response in 12 patients.

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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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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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FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

LifeProNow

The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy). director of the FDA’s Center for Biologics Evaluation and Research.