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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag

Roche Holding AG RHHBY announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational oral therapy inavolisib for treating adult patients with breast cancer.

The NDA is seeking approval for inavolisib in combination with Pfizer’s PFE Ibrance (palbociclib) and AstraZeneca’s AZN Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced/metastatic breast cancer, after recurrence on or within 12 months of completing adjuvant endocrine treatment.

With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Nov 27, 2024.

The FDA’s priority review was based on data from the phase III INAVO120 study, which showed that treatment with the inavolisib-based regimen more than doubled progression-free survival while reducing the risk of disease worsening or death by 57% versus Ibrance and Faslodex alone in the first-line setting.


Though the overall survival data were immature at that time, a clear positive trend was observed.

Based on data from the INAVO120 study, a regulatory application for the inavolisib-based regimen has also been submitted to other global health authorities, including the European Medicines Agency.

Shares of Roche have declined 13.6% so far this year against the industry’s rise of 14.5%.

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HR-positive breast cancer is the most prevalent type of breast cancer and roughly accounts for approximately 70% of the cases.

We note that Pfizer’s Ibrance and AstraZeneca’s Faslodex are both approved for treating breast cancer.

We note that inavolisib is currently being evaluated in two additional company-sponsored late-stage clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.

A phase III study, INAVO121, is evaluating inavolisib in combination with AZN’s Faslodex versus Piqray (alpelisib) plus Faslodex in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy.

Another phase III study, INAVO122, is investigating inavolisib in combination with Perjeta (pertuzumab) plus Herceptin (trastuzumab) for subcutaneous injection (SC) versus Perjeta plus Herceptin for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease.

Zacks Rank & Stock to Consider

Roche currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the healthcare sector is Krystal Biotech, Inc. KRYS, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 28.2%.

KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.

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