Approved for treatment of rare lung cancer, afatinib extended indications

Approved for treatment of rare lung cancer, afatinib extended indications

January 16, 2018 Source: WuXi PharmaTech

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Recently, Boehringer Ingelheim announced that the US FDA has expanded the first-line indications for afatinib (Gilotrif, afatinib) for non-resistant rare EGFR mutations (L861Q, G719X and/or S768I). Treatment of patients with metastatic non-small cell lung cancer (NSCLC).

NSCLC itself is not a rare cancer, but a subset of EGFR-positive NSCLC patients is considered rare. Most EGFR mutation-positive NSCLC cases are common EGFR mutations: exon 19 deletion and L858R. About 10% of NSCLC patients with EGFR mutations have rare mutations. These patients need a targeted drug for treatment.

Afatinib was originally approved by the FDA in 2013 for the treatment of metastatic NSCLC with exon 19 deletion or exon 21 L858R replacement. In 2016, its scope of application was expanded to treat patients with lung squamous cell carcinoma who progressed after platinum-based chemotherapy.

The approval for this expanded indication was based on the results of a Phase 2 clinical trial of LUX-Lung 2 (LL2) with 32 patients and Phase 3 clinical trials LUX-Lung 3 (LL3) and LUX-Lung 6 (LL6). . Among them, 21 patients had a single mutation and the rest had two mutations. One patient with a single S7681 mutation had a duration of remission of 37.3 months; 6 of 8 patients with G719X mutations (75%) had a duration of relief of up to 25.2 months; 12 of 12 patients with L861Q mutations had 7 (58%) showed remission with a duration of relief of 2.8-20.6 months. The most common co-mutation was in S768I and G719X, and 4 of 5 patients developed remission (80%). One of the 2 patients with S768I and L858R mutations had a remission with a duration of relief of more than 34.5 months. Two of the 3 patients with G719X and L861Q mutations had remission, and one patient with L861Q and Del 19 mutations did not.

â–² molecular structure of afatinib (Source: Wikipedia)

Overall, the objective response rate (ORR) for the afatinib group was 66% (95% CI, 47%-81%). Among patients with remission, 52% had a duration of remission ≥ 12 months, and 33% had a duration of remission ≥ 18 months.

The FDA noted that in all studies, ≥20% of patients reported the most common adverse events (AEs) as diarrhea, rash, acne-like dermatitis, stomatitis, paronychia, dry skin, loss of appetite, nausea, vomiting, and itching. For a wider range of indications, 29% of patients treated with afatinib reported severe AEs. Among them, the most common AEs were diarrhea (6.6%), vomiting (4.8%), dyspnea, fatigue, and hypokalemia (1.7% each).

“For patients who have not been proven to date, in addition to chemotherapy, we actually have an evidence-based treatment option in afatinib, which I think will be a very valuable supplement,” Swedish Medical Center Dr. H. Jack West, a chest oncologist at the Cancer Institute, said: "In the past two years, we have learned that EGFR mutations are more than just a simple 'yes or no', the facts are more detailed than this. 88% to 90 % of patients have 1 or 2 common EGFR mutations, but that makes 10% to 12% of EGFR mutations rare. Historically, for these rare mutations, we gave first-generation inhibitors such as erlotinib (Tarceva, erlotinib) or gefitinib (Iressa, gefitinib) was not particularly successful. However, the study of afatinib is better and apparently has some activity for most of them. It is for exon 20 Insertion or T790M is not good, but for many other rare mutations, we now have the option of afatinib."

“With Gilotrif's expanded indications, NSCLC patients with certain EGFR mutations now have approved treatments specifically for these mutations,” said Dr. Sabine Luik, Senior Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim. Approval is the result of our company's commitment to providing meaningful treatment in areas with high medical needs, as well as the unremitting efforts of doctors, researchers and patients involved in the study."

"The L861Q, G719X, or S768I replacement mutations have a poor prognosis and limited treatment options compared to other EGFR mutations," said Dr. Edward Kim of the Levine Cancer Institute at Carolinas Medical Health System. "Approving Gilotrif as these additional non-resistances Targeted therapy for sexual EGFR mutations has significantly changed the treatment strategy for this population."

Reference materials:

[1] FDA Expands Afatinib's Approval for Lung Cancer

[2] Afatinib Approval Expanded for Rare Lung Cancer Treatment

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