Loxo Receives FDA Drug Approval

- November 27th, 2018

The patients eligible for this treatment have few alternative options and represent a high-risk morbidity for surgery.

Loxo Oncology (NASDAQ:LOXO) revealed on after trading hours on Monday (November 26) that its drug Vitrakvi (larotrectinib) received US Food and Drug Administration (FDA) approval to treat solid tumors.

Vitrakvi represents a unique approval as the first ever TRK inhibitor for pediatric and adult patients with solid tumors who have an NTRK gene fusion and no known resistance mutation. The patients eligible for this treatment have few alternative treatment options and represent a high-risk morbidity for surgery.

Data for this approval was based off of overall complete response rate (ORR) and duration of response. The results were pooled from the company’s Phase 1 adult trial, Phase 2 NAVIGATE trial, and Phase ½ pediatric SCOUT trial.

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Patients in the trial identified to have a TRK fusion cancer and treated with Loxo’s drug had an ORR of 75 percent, including a complete response rate of 22 percent.

This approval is from the FDA’s accelerated approval program. Continued approval will be based on verification and description of clinical benefit in confirmatory trials. The drug is awaiting approval in the European Union.

Dr. David Hyman, a global principal investigator for the trial added the drug has shown “clinically meaningful responses in patients” regardless of patient age or tumor types. “We now have the first therapy approved for this genomic alteration, regardless of cancer type,” he added.

The most common side effects from the drug are anemia, fatigue, nausea, dizziness and coughing. Some neurological adverse reactions, which occur in the first three months of treatment consist of delirium, dizziness, and gait disturbance.

Forbes reported that Vitrakvi’s pricing is set at US$32,800 monthly, for oral capsules, or US$393,600 annually. A liquid solution for some children and adults may cost US$11,000.

In 2017, it was announced that Bayer (OTCMKTS:BAYRY,ETR:BAYN) is a global development partner for Vitrakvi’s development. The two companies are also developing Loxo’s other drug, LOXO-195. Both companies will co-promote the products which are being jointly developed in the US, while Bayer is leading ex-US regulatory activities.

As part of Bayer’s partnership, Loxo is providing two patient support programs: the Vitrakvi Commitment Program and the TRAK Assist. These programs are to ensure patients prescribed Vitrakvi can access the medication.

The first program gives a refund opportunity for the payer, patient and third-party payer if the patient hasn’t seen any clinical benefit within 90 days of treatment initiation. Only patients that have tested positive for the NTRK gene fusion are eligible for this program.

The TRAK assist provides other comprehensive reimbursement support and patient assistance services. Both of these programs are run by the Bayer US Patient Assistance Foundation, a charitable organization.

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TRK fusion cancers occur when a patient’s NTRK gene fuses with another unrelated gene, creating an altered TRK protein. This altered protein triggers a signalling cascade and acts as oncogenic drivers to promote the cancer’s growth and survival.

The highest frequency of TRK fusion cancers occurs in infantile fibrosarcoma. Others include thyroid cancer, high-grade gliomas, lung cancer and more.

Loxo is focusing its oncology pipeline on genomically defined cancers specifically towards uniquely dependent single gene abnormalities. The company expects this angle will have the best potential to help the patients with these cancers. Other drugs indications for drug candidates in its pipeline are for B-cell, RET mutation and FGFR cancers.

Bayer is a more diversified company with interests in agriculture and the healthcare industry.

Investor takeaway

Loxo’s share price dipped nearly 10 percent to US$139.10 over the trading period between Monday and Tuesday (November 27).

Since Monday, four analysts have issued notes to investors on Loxo, according to TipRanks. Raymond James analyst Dane Leone reiterated a “Buy” position with a US$235 price target.

Investors are encouraged to follow both Bayer and Loxo’s news about the launch of this product.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

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