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FDA Drug Approvals | 2024 | iPharmaCenter

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Stage III-IVA Cervical cancer








Lung cancer

January 12, 2024

FDA Approved Keytruda for with FIGO 2014 Stage III-IVA cervical cancer

The approval from the U.S. Food and Drug Administration (FDA) for using Merck's Keytruda (pembrolizumab) alongside chemoradiotherapy in treating patients diagnosed with FIGO 2014 Stage III-IVA cervical cancer is a notable development. This regulatory milestone signifies Keytruda as the inaugural anti-PD-1 therapy sanctioned for this specific combination.

This FDA approval marks the third acknowledgment of Keytruda's efficacy in cervical cancer and is the 39th overall approval for Keytruda in the United States.

Merck announced the FDA's approval for Keytruda's use in combination with chemoradiotherapy (CRT) for patients diagnosed with FIGO 2014 Stage III-IVA cervical cancer. The approval is based on the data derived from the Phase 3 KEYNOTE-A18 trial, where the combination of Keytruda and CRT exhibited a 41% risk reduction in disease progression or mortality compared to the placebo plus CRT for patients with FIGO 2014 Stage III-IVA disease. Median PFS remained undetermined in both study groups.

The KEYNOTE-A18, also identified as ENGOT-cx11/GOG-3047, is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial. Carried out in collaboration with the European Network for Gynaecological Oncological Trial (ENGOT) groups and the GOG Foundation, the trial enrolled 1,060 cervical cancer patients without any prior definitive surgery, radiation, or systemic therapy. Among them were 596 patients diagnosed with FIGO 2014 Stage III-IVA cervical cancer and 462 with FIGO 2014 Stage IB2-IIB cervical cancer. Patients were randomly assigned (1:1) to receive either Keytruda combined with cisplatin and radiotherapy or placebo with the same treatment regimen.

The trial demonstrated a statistically significant improvement in progression-free survival (PFS) for the overall study population. In an exploratory subgroup analysis for the 462 patients with FIGO 2014 Stage IB2-IIB disease, the PFS HR estimate was 0.91. Overall survival data were not matured at the time of PFS analysis.

In the subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the Keytruda plus CRT arm experienced a PFS event compared to 94 patients (31%) in the placebo plus CRT arm. Median PFS was not reached in either arm. The 12-month PFS rate was 81% for Keytruda plus CRT versus 70% for placebo plus CRT.

The median exposure duration to Keytruda was 12.1 months, with fatal adverse reactions observed in 1.4% of patients receiving Keytruda in combination with chemoradiotherapy. Serious adverse reactions occurred in 30% of patients. Keytruda discontinuation due to adverse reactions occurred in 7% of patients, with diarrhea being the most common cause. Adverse reactions leading to the interruption of KEYTRUDA occurred in 43% of patients, with anemia, COVID-19, and decreased neutrophil count being the most frequently cited reasons.


February 16, 2024

FDA Approves First Cellular Therapy for Treating Unresectable or Metastatic Melanoma - Amtagvi

The United States Food and Drug Administration (FDA) has granted approval to Amtagvi, marking a significant advancement as the inaugural cellular therapy authorized for managing adult patients with a specific form of skin cancer known as melanoma, which cannot be surgically removed (unresectable) or has spread to other parts of the body (metastatic) after prior treatment with other therapies (a PD-1 blocking antibody, and if positive for BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor).

Melanoma, a type of skin cancer commonly triggered by exposure to ultraviolet light from sources such as sunlight or indoor tanning, while representing only about 1% of all skin cancers, contributes significantly to cancer-related fatalities. Failure to detect and treat melanoma early can result in metastatic disease, with the cancer spreading to other areas of the body.

Amtagvi received approval through the Accelerated Approval pathway, a mechanism through which the FDA may authorize drugs for severe or life-threatening diseases or conditions lacking adequate treatment options, provided the drug demonstrates an effect on a surrogate endpoint reasonably predictive of clinical benefit to patients (improving patient well-being or functionality, or extending survival). This pathway typically grants patients earlier access to a promising therapy while the company conducts further studies to confirm the anticipated clinical benefits. Ongoing confirmation trials are currently underway to validate Amtagvi's clinical efficacy.

The safety and effectiveness of Amtagvi were assessed through a global, multicenter, multicohort clinical study involving adult patients with unresectable or metastatic melanoma who had previously received at least one systemic therapy, including a PD-1 blocking antibody, and if positive for BRAF V600 mutation, a BRAF inhibitor or BRAF inhibitor with a MEK inhibitor. The efficacy was determined based on the objective response rate to treatment and the duration of response. Among the 73 patients treated with Amtagvi at the recommended dosage, the objective response rate was 31.5%, with three patients (4.1%) achieving a complete response and 20 patients (27.4%) showing a partial response. Among responders, 56.5%, 47.8%, and 43.5% maintained responses without tumor progression or death at six, nine, and twelve months, respectively.

Patients receiving Amtagvi may experience prolonged severe low blood count, severe infection, cardiac disorders, or may encounter worsened respiratory or renal function, potentially leading to fatal treatment-related complications. The drug's label carries a Boxed Warning highlighting these risks. Close monitoring for signs and symptoms of adverse reactions is crucial before and after infusion, with treatment adjustment or discontinuation warranted upon symptom manifestation.

The most commonly reported adverse reactions associated with Amtagvi include chills, fever, fatigue, tachycardia (abnormally fast heart rate), diarrhea, febrile neutropenia.


February 16, 2024

Tagrisso combined with chemotherapy garners approval in the United States for individuals with EGFR-mutated advanced lung cancer

AstraZeneca's Tagrisso (osimertinib) in conjunction with chemotherapy has gained regulatory approval in the United States for managing adult patients afflicted with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor-mutated (EGFRm) genes.

The green light from the Food and Drug Administration (FDA), following a Priority Review, hinged on the outcomes of the Phase III FLAURA2 trial, which were published in The New England Journal of Medicine.

Tagrisso coupled with chemotherapy demonstrated a 38% reduction in the risk of disease advancement or mortality compared to Tagrisso monotherapy, the prevailing first-line global standard of care.

Median progression-free survival (PFS), according to investigator evaluation, reached 25.5 months for patients treated with Tagrisso alongside chemotherapy, marking an enhancement of 8.8 months compared to Tagrisso monotherapy (16.7 months).

PFS findings from blinded independent central review (BICR) corroborated those from the investigator's assessment, illustrating a median PFS of 29.4 months with Tagrisso plus chemotherapy, signifying a 9.5-month advancement over Tagrisso monotherapy (19.9 months).

In a prearranged exploratory analysis of patients in the FLAURA2 trial exhibiting brain metastases at baseline, Tagrisso in combination with chemotherapy led to a 42% decline in the risk of central nervous system (CNS) ailment progression or mortality compared to Tagrisso alone as evaluated by BICR. Over a two-year follow-up, 74% of patients receiving Tagrisso with chemotherapy remained free from CNS ailment progression or mortality, in contrast to 54% of patients treated solely with Tagrisso.

Although overall survival (OS) findings remained premature at the second interim analysis (41% maturity), no indication of detriment was observed. The trial continues to monitor OS as a significant secondary endpoint.

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